Heart Failure Center Accreditation Program (HF-CAP) in China: A Prospective Multicenter Cluster Randomized Controlled Trial
Phase: NA
Conditions: Heart Failure
Sponsor: Shanghai Zhongshan Hospital

Protocol 
Version History / Amendment History 
Document Version 
Version 
Date 
Reason for Revision and Summary of 
Changes 
Protocol 
V1.0 
20250204 
Initial version 
Investigator’s Statement 
I will conscientiously fulfill the investigator’s responsibilities in accordance with 
China GCP requirements, and I will personally participate in or directly supervise this 
clinical study. We have read and confirmed this protocol, and agree to its scientific 
and ethical soundness. We will fulfill relevant responsibilities in accordance with 
Chinese laws and regulations, the Declaration of Helsinki, China GCP, and the 
provisions of this study protocol, and will implement the study only after approval by 
the academic committee and the ethics committee. Unless measures must be taken to 
protect the safety, rights, and interests of subjects, we will keep this study protocol 
confidential. 
Study Site: Zhongshan Hospital, Fudan University 
Principal Investigator: Zhou Jingmin 
Principal Investigator (Signature): 
Date of Signature: 
Table of Contents 
Protocol Summary 4 
Abbreviations 7 
I. Background 8 
II. Study Objectives 9 
2.1 Primary Objectives 9 
2.2 Secondary Objectives 9 
III. Study Overview 10 
3.1 Overall Study Design and Plan 10 
3.2 Sample Size and Grouping Method 10 
3.3 Randomization and Blinding 10 
3.4 Study Flow Chart 11 
IV. Study Population 11 
4.1 Inclusion Criteria 11 
4.2 Exclusion Criteria 12 
4.3 Withdrawal Criteria 12 
4.4 Exclusion After Enrollment (Protocol Violation) 12 
V. Endpoints 12 

5.1 Primary Endpoints 12 
5.2 Secondary Endpoints 12 
5.3 Safety Endpoints 13 
5.4 Exploratory Endpoints (if applicable) 13 
VI. Study Procedures 13 
6.1 Study Steps and Related Assessments 13 
6.2 Investigational Product (if applicable) 17 
6.3 Concomitant Medications and Treatments (if applicable) 17 
6.4 Dose Adjustment (if applicable) 17 
6.5 Study Completion 17 
6.6 Early Termination or Suspension 18 
6.7 Clinical Observation, Follow-up, and Measures to Ensure Subject Compliance 18 
VII. Adverse Event Collection and Reporting 18 
7.1 Definitions of Adverse Events 18 
7.2 Recording and Reporting of Adverse Events 18 
7.3 Risk Prevention and Management 19 
VIII. Data Management 19 
IX. Statistical Analysis 20 
9.1 Sample Size Estimation 20 
9.2 Definition and Selection of Analysis Sets 0 
9.3 Statistical Methods and Analyses 0 
X. Ethics-Related Considerations 1 
10.1 Ethics Committee Review 1 
10.2 Informed Consent 2 
XI. Confidentiality Measures 2 
XII. Expected Study Timeline and Completion Date 2 
XIII. References 2 
 
Protocol Summary 
Protocol Title 
China Heart Failure Center Accreditation Program: A Prospective Multicenter Cluster 
Randomized Controlled Trial 
Study Objective 
To evaluate the impact of HF-CAP versus usual care on heart failure management 
quality and 1-year outcomes in heart failure patients (a composite endpoint of HF 
rehospitalization or all-cause death). 
Study Endpoints 
Primary endpoints: 
There are two primary endpoints: (1) HF rehospitalization and all-cause mortality 
within 12 months after discharge; (2) heart failure management quality score. 

Secondary endpoints: 
• 
First HF rehospitalization; 
• 
Number of HF rehospitalizations; 
• 
All-cause readmission; 
• 
All-cause mortality. 
Overall Design 
A multicenter, open-label, cluster-randomized, controlled trial. 
Sample Size 
80 centers, 6,240 patients. 
Grouping 
Cluster randomization. 
Inclusion / Exclusion Criteria 
Center inclusion criteria: 
1. Registered on the China Heart Failure Center website; applicants for 
Standard/Primary-level HF centers have already reported ≥300/100 HF cases, 
and continuously report ≥10/8 HF cases per month; 
2. Capable of completing quality improvement measures. 
Subject inclusion criteria: 
1. Age ≥18 years; 
2. Heart failure is the primary reason for hospitalization. 
Whether hospitalization is due to heart failure will be determined by local 
investigators, but should meet the following criteria: 
• 
Symptoms of HF (e.g., dyspnea, fatigue), signs (e.g., elevated jugular venous 
pressure, peripheral edema), or laboratory/imaging evidence (e.g., chest X-ray 
showing pulmonary congestion, elevated natriuretic peptides, 
echocardiographic evidence of structural or functional cardiac abnormality); 
• 
Treatment directed at acute or chronic HF etiology (e.g., intravenous diuretics, 
vasodilators, inotropes, or revascularization). 
Subject exclusion criteria: 
1. Life-threatening conditions other than HF with expected survival <1 year, 
such as malignancy; 
2. Unable to complete follow-up. 

Intervention 
China Heart Failure Center Accreditation Program (HF-CAP). 
Withdrawal Criteria 
If a participant stops participation before the planned end of the trial, it is considered 
withdrawal. This may be initiated by the participant or the investigator. Participants 
may voluntarily withdraw consent at any time for any reason. A participant is defined 
as withdrawn when all of the following are met: 
1. Refuses to continue participation; 
2. Refuses further visits or assessments; 
3. Refuses further trial-related contact. 
Statistical Analysis Plan 
1. Descriptive analysis: Categorical variables will be described using frequency 
and proportion; continuous variables will be described using mean, standard 
deviation, median, 25th and 75th percentiles, maximum and minimum. 
2. Baseline demographic analysis: Primarily descriptive. For subgroup 
comparisons as applicable: for categorical variables, use likelihood-ratio χ² 
test; when >25% of cells have expected counts <5, use Fisher’s exact test. For 
normally distributed continuous variables, use independent-samples t test; for 
non-normally distributed continuous variables, use Wilcoxon rank-sum test. 
3. Efficacy analysis: 
o Primary endpoint analysis: 
(1) The primary clinical endpoint will use the Kalbfleisch–Prentice 
nonparametric cumulative incidence function to estimate cumulative 
incidence over follow-up. A stratified Cox proportional hazards model 
will estimate hazard ratios (HRs) and 95% confidence intervals (CIs) 
to evaluate differences in event risk between groups, accounting for 
cluster effects. 
(2) The second primary endpoint, HF management quality score, will 
be analyzed using a mixed-effects model, treating hospital as a random 
effect to account for within-hospital clustering, and using a compound 
symmetry covariance structure to model correlations among repeated 
observations within the same participant. 
o Secondary endpoints: Fine–Gray competing-risk models will be used 
to avoid bias from competing events (e.g., death from other causes), 
accounting for cluster effects. 
o Subgroup analysis: Prespecified subgroups include age, sex, 
hypertension, diabetes, chronic kidney disease (defined as serum 
creatinine >1.5 mg/dL), other baseline treatments, and frailty/poor 
condition (defined by baseline NYHA and NT-proBNP). The impact 
on primary outcomes and interaction effects will be explored. No 
multiplicity adjustment will be performed. 

o Sensitivity analyses: 
Excluding early events: exclude events occurring within 10 days after 
randomization and repeat the primary analysis to wash out pre-
randomization effects. 
Tipping-point analysis: for subjects with potential underreporting risk, 
progressively add assumed events and fit Weibull models to assess 
robustness under different missing-event scenarios. 
 
Abbreviations 
ACEI: Angiotensin-Converting Enzyme Inhibitor, angiotensin-converting enzyme 
inhibitor 
AI: Artificial Intelligence, artificial intelligence 
ARB: Angiotensin II Receptor Blocker, angiotensin II receptor blocker 
ARNI: Angiotensin Receptor–Neprilysin Inhibitor, angiotensin receptor–neprilysin 
inhibitor 
BNP: B-type Natriuretic Peptide, B-type natriuretic peptide 
eCRF: electronic Case Report Form, electronic case report form 
EDC: Electronic Data Capture, electronic data capture system 
GDMT: Guideline-Directed Medical Therapy, guideline-directed medical therapy 
HF-CAP: Heart Failure Center Accreditation Program, China Heart Failure Center 
Accreditation Program 
HFrEF: Heart Failure with reduced Ejection Fraction, heart failure with reduced 
ejection fraction 
LVEDD: Left Ventricular End-Diastolic Diameter, left ventricular end-diastolic 
diameter 
LVEF: Left Ventricular Ejection Fraction, left ventricular ejection fraction 
MRA: Mineralocorticoid Receptor Antagonist, mineralocorticoid receptor antagonist 
NT-proBNP: N-terminal pro–B-type Natriuretic Peptide, N-terminal pro–B-type 
natriuretic peptide 
NYHA: New York Heart Association, New York Heart Association 
SGLT-2i: Sodium-Glucose Cotransporter-2 Inhibitor, sodium-glucose cotransporter-2 
inhibitor 
 
I. Background 
Heart failure (HF) affects more than 64 million people worldwide and has become a 
major clinical and public health problem, especially among those aged 65 years and 
older [1]. China is the world’s second most populous country, accounting for 
approximately 17.7% of the world’s population. There are approximately 12.10 
million HF patients in China, accounting for more than 10% of HF patients 

worldwide, and the annual healthcare costs related to HF exceed RMB 250 billion 
(USD 31 billion) [2]. 
HF treatment has made substantial progress over the past decades, particularly in 
heart failure with reduced ejection fraction (HFrEF), where multiple pharmacologic 
and device therapies have been proven to significantly improve prognosis and quality 
of life, driving updates of HF guidelines globally [3–5]. However, in real-world 
clinical practice, there remains a substantial gap between guideline recommendations 
and the use of guideline-directed medical therapy (GDMT). The CHAMP-HF registry 
reported that among outpatients with HFrEF, only 73%, 67%, and 33% received 
ACEI/ARB/ARNI, beta-blockers, and MRA, respectively [6]. Sumarsono et al. [7] 
recently reported that in newly diagnosed outpatients with HFrEF in the United 
States, GDMT utilization was similarly suboptimal: at 3 months after diagnosis, the 
use rates of ACEI/ARB/ARNI, beta-blockers, and MRA were 55.3%, 55.5%, and 
18.4%, respectively; by 12 months after diagnosis, the rates increased only to 65.2%, 
64.3%, and 24.7%, respectively. 
There are many quality improvement programs in hospitals and healthcare systems 
aimed at optimizing GDMT in HFrEF patients, but the results have been mixed. In the 
United States, a nationwide guideline-based quality improvement initiative, Get With 
The Guidelines (GWTG), includes a HF program (GWTG-HF). Compared with non-
participating hospitals during the same period, participating hospitals had a higher 
proportion of HF patients receiving standardized HF diagnosis and treatment, but did 
not reduce the risk of 30-day readmission and mortality [8]. More recently, two large 
randomized controlled trials showed that intensified quality improvement measures or 
patient-centered transitional care services did not significantly affect GDMT use or 
clinical outcomes. The CONNECT-HF trial showed that, compared with usual care, 
an intensified quality improvement intervention involving patient education and post-
discharge follow-up did not reduce the composite endpoint of HF rehospitalization or 
all-cause death, nor did it improve the HF management quality score [9]. In the 
PACT-HF study, there was also no significant difference between the intensified 
management group and the usual care group in the composite outcome of all-cause 
readmission, emergency department visit, or death at 3 months after discharge (HR 
[CI]: 0.99 [0.83–1.19], P=0.93) [10]. 
The Heart Failure Center Accreditation Program (HF-CAP) in China is a nationwide 
HF quality improvement initiative launched in 2017 under the leadership of the 
Chinese Medical Doctor Association, aiming to improve HF management [11–12]. 
This prospective cohort study is the largest cohort study among HF patients in China 
and is also the first to comprehensively describe characteristics as well as short- and 
long-term outcomes of HF patients in China [13]. Registry data from HF center 
development show that the use of BNP/NT-proBNP and echocardiography for HF 
diagnosis increased year by year, the proportion of patients discharged on GDMT 
increased year by year, and 1-year mortality after discharge showed a downward 
trend. As a real-world prospective cohort study, although extensive adjustment for 

potential confounders was performed, inherent limitations of observational studies 
mean that the risk of unknown confounding cannot be excluded; causal inference 
cannot be directly made, and effectiveness outcomes cannot be definitively attributed 
to the intervention itself. Therefore, the effectiveness of the accreditation program 
requires further validation. 
This project plans to conduct a multicenter, prospective, cluster-randomized, 
controlled clinical trial in China to evaluate whether the HF-CAP program improves 
outcomes in HF patients. 
 
II. Study Objectives 
2.1 Primary Objectives 
Two primary objectives: 
(1) To evaluate the impact of HF-CAP versus usual care on 1-year outcomes in HF 
patients; 
(2) To evaluate the effect of HF-CAP versus usual care on improving HF 
management quality. 
2.2 Secondary Objectives 
To evaluate: 
• 
First HF rehospitalization; 
• 
Number of HF rehospitalizations; 
• 
All-cause readmission; 
• 
All-cause mortality. 
2.3 Exploratory Objective 
To determine the effectiveness of HF-CAP in reducing healthcare system costs within 
1 year after discharge for HF patients. 
 
III. Study Overview 
3.1 Overall Study Design and Plan 
This study is a multicenter, open-label, cluster-randomized, controlled study designed 
to verify the effectiveness of the HF-CAP management strategy versus usual HF 
management in improving HF management quality scores and outcomes during the 
12-month period after discharge. 

3.2 Sample Size and Grouping Method 
The total sample size is 6,240. The intervention group and the control group will each 
include 3,120 patients. 
Grouping method: The study plans to include 80 tertiary hospitals and 80 secondary 
hospitals. Tertiary and secondary hospitals will be stratified, and within each hospital 
level, hospitals will be randomized 1:1 by cluster (hospital) allocation. Each hospital 
will enroll 40 patients. 
Intervention group: Will receive HF-CAP management, including requiring 
hospitals to establish a multidisciplinary HF management team, set up dedicated HF 
beds and HF follow-up clinics, conduct regular staff training and patient/family 
education, establish a robust outpatient follow-up mechanism, and set quality control 
targets. An HF-CAP Expert Committee will form a trained and experienced team of 
HF management experts to conduct online document review, on-site review and 
guidance, and to assess and guide high-quality HF care during index hospitalization 
(including at discharge) and during 1-year post-discharge outpatient follow-up. For 
example, HF-CAP verification experts will meet the HF management team on site, 
review existing quality control indicators, standardize 制度建设 (system building), 
audit on-site operational cases, and provide regular guidance for training, typical case 
discussions, quality control meetings, and issue quality control data reports and 
feedback based on uploaded data. 
Control group: Will receive usual HF management, with requirements to regularly 
upload patient data and routinely monitor data quality to ensure normal data 
collection, but without other guidance or interventions. 
All participants in the trial will agree to follow-up at the enrolling hospital after 
discharge (1 week, 1 month, 3 months, and 12 months). Clinical data, medication use, 
and outcomes will be uploaded to the China HF center registry platform. 
3.3 Randomization and Blinding 
This is a multicenter, cluster-randomized trial. The unit of randomization is the 
hospital. Trial assessments begin during index hospitalization and continue through 
12 months of follow-up. Stratified randomization will be used: hospitals will be 
randomized 1:1 to the intervention group (HF-CAP program management) or the 
control group (usual care), stratified by hospital level (tertiary vs secondary) to ensure 
balance within strata. Randomization will be performed by an independent 
biostatistician using a central computer program. Randomization will be completed 
before collecting baseline HF management information at each center. Subjects will 
not be informed of the allocation between HF-CAP program management and usual 
care. 

3.4 Study Flow Chart 
Figure 1. Technical route and flow of the study. 
 
IV. Study Population 
Eligible patients are those hospitalized primarily for HF. Given the pragmatic design, 
inclusion and exclusion criteria are kept as simple as possible. 
4.1 Inclusion Criteria 
Center inclusion criteria: 
1. Registered on the China HF Center website; applicants for Standard/Primary-
level HF centers have already reported ≥300/100 HF cases and continuously 
report ≥10/8 HF cases per month; 
2. Capable of completing quality improvement measures. 
Subject inclusion criteria: 
1. Age ≥18 years; 
2. HF is the primary reason for hospitalization. 
Whether hospitalization is due to HF will be determined by local investigators, but 
should meet the following criteria: 
• 
HF symptoms (e.g., dyspnea, fatigue), signs (e.g., elevated jugular venous 
pressure, peripheral edema), or laboratory/imaging evidence (e.g., chest X-ray 
showing pulmonary congestion, elevated natriuretic peptide levels, 
echocardiographic evidence of structural or functional cardiac abnormality); 
• 
Treatment directed at acute or chronic HF etiology (e.g., intravenous diuretics, 
vasodilators, inotropes, or revascularization). 
4.2 Exclusion Criteria 
1. Life-threatening conditions other than HF with expected survival <1 year, 
such as malignancy; 
2. Unable to complete follow-up. 
4.3 Withdrawal Criteria 
If a participant stops participating before completion, it is considered withdrawal. 
This may be initiated by the participant or the investigator. Participants may 

voluntarily withdraw consent at any time for any reason. A participant is defined as 
withdrawn when all of the following criteria are met: 
• 
 
1. Refuses to continue participation; 
• 
 
2. Refuses further visits or assessments; 
• 
 
3. Refuses further trial-related contact. 
4.4 Exclusion After Enrollment (Protocol Violation) 
• 
Subjects who violate the protocol inclusion criteria; 
• 
Subjects who meet the protocol exclusion criteria. 
 
V. Endpoints 
5.1 Primary Endpoints 
There are two primary endpoints: (1) HF rehospitalization and all-cause death within 
12 months after discharge; (2) HF management quality score. 
5.2 Secondary Endpoints 
Within 12 months after discharge: 
1. First HF rehospitalization; 
2. Number of HF rehospitalizations; 
3. All-cause readmission; 
4. All-cause death. 
HF rehospitalization is defined as hospitalization due to worsening HF, or an 
emergency visit requiring intravenous diuretic therapy. 
All-cause readmission is defined as hospitalization due to worsening of any disease, 
or an emergency visit lasting more than 12 hours. 
5.3 Safety Endpoints 
At each visit, any adverse events will be recorded. Primary safety endpoints include 
hypotension, renal dysfunction, hyperkalemia, hypokalemia, arrhythmia, etc. 
5.4 Exploratory Endpoints (if applicable) 

• 
Compare direct medical costs, direct non-medical costs, and indirect costs 
within 12 months between intervention and control groups; 
• 
Compare HF-CAP effects in specific subgroups, including different hospital 
levels, females vs males, older vs younger, diabetes vs non-diabetes, 
hypertension vs non-hypertension, CKD vs non-CKD, ischemic vs non-
ischemic, sinus rhythm vs atrial fibrillation; 
• 
Explore optimal GDMT dosing for the Chinese population; 
• 
Explore onset time and duration of HF-CAP effectiveness. 
 
VI. Study Procedures 
6.1 Study Steps and Related Assessments 
(1) Hospital screening phase: Hospitals registered on the China HF Center website 
that continuously upload data but have not applied for accreditation will be screened. 
Based on hospital level and annual HF admission volume, eligibility will be assessed 
against inclusion/exclusion criteria. Hospitals will be stratified by level, HF volume, 
and care capability into Standard and Primary-level categories. Hospitals meeting 
inclusion criteria, not meeting exclusion criteria, and willing to participate will be 
preliminarily screened. These hospitals will submit the study for ethics review; those 
obtaining ethics approval will become formally screened and enter the randomization 
phase. 
(2) Randomization phase: The unit of randomization is the hospital. Stratified 
randomization will ensure balance within strata; both Standard and Primary-level 
centers will be randomized 1:1 into the HF-CAP intervention group and the usual care 
group. 
(3) Intervention and follow-up phase: Intervention hospitals will implement a series 
of HF-CAP management measures under guidance of the HF-CAP Expert Committee. 
Usual care hospitals will not receive any intervention and will manage HF patients as 
usual. 
After randomization, each participating unit should introduce the study to each HF 
patient who meets inclusion criteria and does not meet exclusion criteria. Patients who 
provide informed consent are successfully enrolled. Standard HF centers will 
consecutively enroll the first 10 non-selected patients each month in order of 
admission time; Primary-level HF centers will consecutively enroll the first 8 non-
selected patients each month in order of admission time. 
All patients will have baseline data collected and uploaded to the HF Center EDC 
system, including: 

• 
Sociodemographic characteristics: sex, age, height, weight, etc.; 
• 
Socioeconomic characteristics: education level, employment status, insurance 
type; 
• 
Medical history: HF symptoms, NYHA class, disease duration, etiology, 
triggers, comorbidities, personal history, family history, etc.; 
• 
Physical examination: blood pressure, heart rate, oxygen saturation, jugular 
venous distention, lung rales, lower extremity edema, etc.; 
• 
Tests: ECG, echocardiography, 6-minute walk distance; 
• 
Laboratory tests: CBC, liver and renal function, electrolytes, BNP/NT-
proBNP, glucose, lipids; 
• 
Medications: HF medications, cardiovascular medications, other medications; 
• 
In-hospital outcomes. 
All patients are required to complete and upload follow-up data at 1 week, 1 month 
(±7 days), 3 months (±14 days), and 12 months (±28 days) after discharge in the HF 
Center EDC system. 
The 1-week follow-up requires telephone follow-up only to collect HF 
rehospitalization and survival status. 
The 1-month, 3-month, and 12-month follow-ups should be conducted on site 
whenever possible; telephone follow-up is allowed if an on-site visit cannot be 
completed. Follow-up includes symptom and sign assessment, NYHA class, vital 
signs (blood pressure, heart rate), weight, CBC, liver and renal function, electrolytes, 
BNP or NT-proBNP, ECG, medication record, and endpoint event collection. 
Echocardiography and 6-minute walk test will be performed at 3 and 12 months. 
Table 1. Schedule of Assessments and Time Points 
Stage 
Before 
discharge 
Post-
discharge 
follow-up 
 
 
 
Visit 
V0 
V1 
V2 
V3 
V4 
Time 
 
7 days 
1 month 
±7 days 
3 months 
±14 days 
12 months 
±28 days 
Informed consent 
obtained 
× 
 
 
 
 
Inclusion/exclusion 
criteria 
× 
 
 
 
 
Sociodemographic 
characteristics 
× 
 
 
 
 
Medical history 
× 
 
 
 
 
Symptoms 
× 
 
× 
× 
× 

Stage 
Before 
discharge 
Post-
discharge 
follow-up 
 
 
 
Blood pressure 
× 
 
× 
× 
× 
Heart rate 
× 
 
× 
× 
× 
Oxygen saturation 
× 
 
× 
× 
× 
Physical exam 
× 
 
× 
× 
× 
12-lead ECG 
× 
 
× 
× 
× 
Echocardiography 
× 
 
 
× 
× 
CBC 
× 
 
× 
× 
× 
Fasting glucose 
× 
 
× 
× 
× 
HbA1c 
× 
 
× 
× 
× 
Lipids 
× 
 
× 
× 
× 
Liver function 
× 
 
× 
× 
× 
Renal function 
× 
 
× 
× 
× 
Electrolytes 
× 
 
× 
× 
× 
BNP or NT-proBNP 
× 
 
× 
× 
× 
6-minute walk distance × 
 
 
× 
× 
Medication use 
× 
 
× 
× 
× 
Endpoint events 
 
× 
× 
× 
× 
HF-CAP Program 
HF-CAP management measures include the following: 
Heart failure center accreditation 
HF center accreditation can leverage multiple resources of the program to improve HF 
management quality. 
1. Accreditation is a measure of HF management quality. Only HF centers 
maintaining high standards for performance outcomes can obtain and maintain 
accreditation. Therefore, successful accreditation indicates that HF 
management at the center meets national standards. 
2. Accreditation and national/regional HF network support: provide technical 
support and solutions to enable bidirectional referral. 
3. Training and educational resources: access to various online educational 
resources provided by the program, including web-based training courses, 
learning materials, the latest national and international guidelines and expert 
interpretation, and case discussions; members may receive funding support to 

attend regional program training courses and exchange seminars to understand 
program progress and work plans, share experiences in improving HF quality, 
and discuss best practices. 
4. On-site exchange: as needed, conduct on-site visits to excellent centers with 
better HF management quality to promote dissemination of experience. 
Education and training 
HF-CAP staff training program: 
Provide training for multidisciplinary teams at accredited HF centers: 
1. Experts from the China HF Center Alliance and regional HF center alliances 
help centers identify major quality problems, propose improvement measures, 
and promote problem-oriented quality improvement. 
2. Regional training courses: program progress summary, training, and 
experience exchange. 
3. On-site communication: as needed, staff will visit higher-quality centers for 
on-site visits and exchange to promote experience dissemination. 
4. Web-based courses (documents, slides, videos, etc.): participating centers can 
browse and download via the program website using dedicated usernames and 
passwords. 
5. Other educational materials: academic conference presentations and 
exchanges, brochures, pocket guides with program logos, etc. 
HF-CAP patient education program: 
Intervention 
Details 
Exercise and 
rehabilitation 
guidance 
Recommend different intensities of exercise according to 
cardiac function; reduce sedentary behavior; increase moderate-
intensity exercise; proceed gradually; encourage participation in 
recommended exercise forms and community group activities; 
how to avoid or reduce exercise-related injuries. 
Sodium restriction 
In acute HF with volume overload, restrict sodium intake to <2 
g/day; strict sodium restriction is not recommended for mild or 
stable HF. 
Fluid restriction 
1.5–2 L/day for severe HF; mild-to-moderate symptomatic HF 
does not benefit from routine fluid restriction. 
Nutrition and diet 
Low-fat diet; smoking cessation; abstain from alcohol; weight 
loss for obese patients; nutritional support for cardiac cachexia. 
Weight monitoring A sudden weight gain >2 kg within 3 days should be considered 
water and sodium retention. 

Intervention 
Details 
Management of 
blood pressure, 
lipids, glucose 
Control blood pressure, lipids, and glucose within appropriate 
ranges. 
Psychological and 
mental guidance 
Maintain a positive and optimistic attitude; comprehensive 
emotional intervention such as psychological down-regulation; 
consider anxiolytics or antidepressants when necessary and 
appropriate. 
Medication 
guidance 
Explain the medication list including name, dose, timing, 
frequency, purpose, adverse reactions, precautions; print the 
medication list to improve adherence. 
Follow-up plan 
Explain follow-up schedule and purpose in detail; 
individualized follow-up may be recommended (e.g., 2 weeks, 1 
month, 3 months, 6 months, 1 year, 2 years post-discharge) with 
timely medical intervention based on results. 
Self-assessment 
and management of 
symptoms 
How to detect early worsening of HF symptoms and how to 
manage it. 
Continuous improvement measures 
Typical case discussion meetings 
Select typical cases with rescue delay or decision errors for analysis; multidisciplinary 
team meets to discuss and analyze. Core departments should participate; held once 
every 2 months. 
Quality improvement meetings 
Conduct periodic data analysis of HF center operation to affirm achievements, 
identify problems, and formulate improvement measures. Core departments should 
participate; held once every 3 months. 
6.2 Investigational Product (if applicable) 
Not applicable. 
6.3 Concomitant Medications and Treatments (if applicable) 
Not applicable. 
6.4 Dose Adjustment (if applicable) 
Not applicable. 
6.5 Study Completion 

All patients complete the final visit. 
6.6 Early Termination or Suspension 
The study will be terminated or suspended early if unexpected, significant, or 
unacceptable risks to participants are identified, or if major protocol errors are found 
during study conduct. 
6.7 Clinical Observation, Follow-up, and Measures to Ensure Compliance 
Participant adherence will be regularly monitored and evaluated through data 
monitoring in the Zhongshan HF database. 
 
VII. Adverse Event Collection and Reporting 
7.1 Definitions of Adverse Events 
Adverse event (AE): Any adverse medical event occurring during a medical device 
clinical trial, regardless of whether it is related to the investigational medical device or 
drug. 
Serious adverse event (SAE): An event occurring during the clinical trial that results 
in death or severe deterioration of health, including life-threatening illness or injury, 
permanent defect in body structure or function, requiring hospitalization or 
prolongation of hospitalization, requiring medical or surgical intervention to prevent 
permanent defect in body structure or function; fetal distress, fetal death, congenital 
anomaly, or birth defect. 
7.2 Recording and Reporting of Adverse Events 
For any AE occurring in the trial, the investigator shall take appropriate treatment 
measures and manage actively; then, according to the participant’s condition and AE 
control, the investigator will determine subsequent treatment and follow-up. 
Any AE, including subjective discomfort and laboratory abnormalities, must be taken 
seriously, carefully analyzed, and managed to protect participant safety. 
Study staff shall record all AEs in detail in the EDC, including: description of AE and 
related symptoms, time of occurrence, severity, duration, measures taken, final 
outcome, and relationship to the clinical trial, etc. 
All AEs shall be followed until resolution, or until the investigator judges the 
condition is “chronic,” “stable,” or “relieved.” If the trial ends, follow-up continues 
until the last follow-up visit. These AEs shall be recorded in the EDC. 

Serious adverse event: As defined above, including death or severe deterioration, 
life-threatening illness or injury, permanent defect, hospitalization or prolonged 
hospitalization, intervention to avoid permanent defect, fetal distress/death, congenital 
anomaly/defect, etc. 
Record clinically significant AEs from the time the subject signs informed consent 
until the end of follow-up (history/baseline conditions without clear worsening may 
be omitted). Planned hospitalization for existing disease or protocol-required follow-
up without severe deterioration, or elective surgery, is not recorded as an SAE. 
7.3 Risk Prevention and Management 
This study does not involve implantable medical devices or drug trials, therefore it 
will not bring additional risks. 
 
VIII. Data Management 
This study will use the existing electronic data capture system (EDC) of the HF center 
to collect and manage trial data. Data management shall comply with the “Good 
Clinical Practice for Medical Device Trials,” the “Technical Guideline for Clinical 
Trial Data Management,” and the “Guidance on Electronic Data Capture in Clinical 
Trials,” to ensure the authenticity, integrity, accuracy, and reliability of trial data. 
Data entry and verification: 
Investigators or clinical research coordinators shall complete and submit eCRFs 
within the specified time after each subject visit. Monitors, data managers, and 
medical personnel shall review data item by item. Queries identified during review 
will be sent to investigators in the EDC as data queries until closed. The data manager 
may close system-generated queries and data manager–generated queries; clinical 
monitors may close monitor-generated queries; medical personnel may close medical 
personnel–generated queries. After data cleaning, investigators sign to confirm 
reviewed eCRFs; audit trails of data modifications will be retained in the system. 
External data management: 
Based on an external data transfer protocol, including but not limited to data 
categories, data providers, data contents and formats, transfer methods, transfer 
frequency, etc. 
Data review: 
Before database lock, the principal investigator, sponsor, statistician, and data 
manager will jointly conduct final review of all data queries, dropouts and protocol 
deviations, concomitant medications, and AEs, and determine each case’s analysis set 
(including FAS, PPS, SS), missing value determination, and outlier handling. 

Database lock: 
The data manager will develop a database lock checklist. After lock conditions are 
met, relevant personnel (sponsor, principal investigator, biostatistician, clinical project 
manager, data manager) will jointly approve database lock. 
 
IX. Statistical Analysis 
9.1 Sample Size Estimation 
1. Total sample size 
There are two primary endpoints: (1) first HF rehospitalization or death within 12 
months after discharge; (2) improvement in HF management quality score. 
Individual HF management quality score = (actual score − lowest possible score) / 
(highest possible score − lowest possible score). 
Each participant may have a different total number of quality indicator opportunities 
(highest possible score). If a participant does not meet the eligibility criteria for 
certain quality indicators, those indicators will not be counted in the score. For 
example, if a participant does not have atrial fibrillation, they are not eligible for the 
anticoagulation indicator for AF. Similarly, if a participant has contraindications to 
beta-blockers, they are not eligible for that indicator. Eligibility for each quality 
indicator will be determined at baseline and carried forward during follow-up. The 
analysis will compare improvement from baseline to 1 year or the last recorded study 
visit. 
The planned overall sample size is 120 hospitals, with an average cluster size of 52 
patients (total ~6,240 patients), assuming: a 15% relative reduction in first HF 
rehospitalization or death in the intervention group, a 30% event rate in the control 
group, an intracluster correlation coefficient (ICC) of 0.01, a coefficient of variation 
of cluster size of 0.65, power (1−β) of 85%, and overall type I error of 0.05. For the 
clinical endpoint (HF rehospitalization or death), type I error is allocated 0.04; for the 
quality indicator endpoint, type I error is allocated 0.01. For the composite quality 
score, assume a 10% improvement rate in the control group within 12 months, and an 
absolute improvement rate of 20% in the intervention group; thus the planned sample 
size has >90% power to detect a 10% absolute improvement in the intervention group. 
The study centers are distributed nationwide. To avoid patients seeking care and 
transferring across multiple centers, enrolling centers are within 50 km physical 
distance. During 12-month follow-up, the probability of cross-over care is small 
(~5%), and small cross-over is consistent with clinical practice. Therefore, cross-over 
is ignored in sample size estimation. 

2. Sample size allocation and rationale 
This trial will be conducted in multiple clinical trial institutions simultaneously. In 
principle, enrollment numbers will be distributed as evenly as possible across centers 
to ensure adequate representativeness. However, considering feasibility and 
enrollment progress, enrollment numbers may be adjusted according to actual 
conditions, striving to keep enrollment size relatively balanced across centers. 
9.2 Definition and Selection of Analysis Sets 
Analysis sets: Statistical analyses will be performed based on the following 
populations. The analysis populations will be clearly defined before statistical 
analysis begins. This study includes: 
• 
Full Analysis Set (FAS): Defined according to the Intention-To-Treat (ITT) 
principle; a dataset consisting of all subjects who participated in the trial and 
received the study product treatment. 
• 
Per-Protocol Set (PPS): A subgroup of treated subjects who completed the 
trial and excluded those with major protocol violations (e.g., violation of 
inclusion/exclusion criteria, dropout during the trial leading to inability to 
provide primary endpoint data, or circumstances severely affecting evaluation 
of primary endpoints). 
Primary endpoint analyses will be conducted on both FAS and PPS. In addition, 
baseline demographics and secondary endpoint analyses will be conducted on FAS; 
safety evaluation is also planned on FAS (therefore SS is not defined separately). 
9.3 Statistical Methods and Analyses 
Baseline demographic analysis: Primarily descriptive. Data will be summarized and 
analyzed at both the cluster level and the participant level, with adjustment for cluster 
effects. For continuous variables, mean, standard deviation, median, 25th percentile, 
and 75th percentile will be used to compare baseline characteristics between groups; 
for categorical variables, counts and percentages will be used. For continuous 
variables, Wilcoxon rank-sum test will be used; for categorical variables, chi-square 
test or Fisher’s exact test will be used. All trial objectives will be analyzed under the 
ITT principle. 
Primary endpoint analysis: Two primary endpoints: 
1. Composite endpoint of HF rehospitalization or all-cause death within 12 
months after discharge: Kaplan–Meier cumulative risk method will be used to 
calculate event rates in each group. Due to potential clustering within centers, 
Cox models with shared frailties will be used. Demographic and baseline 
clinical characteristics will be included as covariates, and the treating hospital 

will be included as a random effect, to estimate adjusted HRs and 95% CIs to 
evaluate differences in event risk between intervention and control groups. 
2. Improvement in HF management quality score: Compare improvement from 
baseline to 1 year or last recorded visit. A mixed-effects linear model will 
compare score improvement between groups, including the treating hospital as 
a random effect. Correlation within hospital will be considered, and mean 
change and 95% CI will be reported. 
Prespecified subgroup analyses: Center characteristics (tertiary vs secondary; 
geographic regions: western, eastern, central, and northeastern), age, sex, 
hypertension, diabetes, chronic kidney disease (serum creatinine >1.5 mg/dL), other 
baseline treatments, and frailty/poor condition (baseline NYHA, NT-proBNP). Effects 
on primary outcomes and interaction effects will be explored. No multiplicity 
adjustment will be performed. 
Missing data strategy: Covariate missing data will not be handled. For outcome 
variables, loss to follow-up will be controlled within 10%. For patients who withdraw 
or are lost to follow-up before 12 months and have not experienced a primary 
endpoint event, the crude 12-month primary endpoint event risk will be analyzed; 
multiple imputation will not be performed. For quality improvement values, LOCF 
will be used. 
Sensitivity analyses: 
(1) Exclude early events: exclude events occurring within 10 days after randomization 
and repeat primary analysis to wash out pre-randomization effects. 
(2) Tipping-point analysis: for subjects with potential underreporting risk, 
progressively add assumed events, fit Weibull models, and assess robustness under 
various missing-event scenarios. 
(3) Analyses under different covariate missing-data strategies: (i) no handling; (ii) 
deletion; (iii) imputation. a) Mean/median/mode imputation: continuous quantitative 
data can be imputed with mean or median; discrete quantitative data can be imputed 
with mode. b) Build regression models to impute missing values. 
(4) Analyses under different outcome event missing-data strategies: (i) deletion, no 
multiple imputation; (ii) worst-case strategy: patients who withdraw or are lost to 
follow-up before 12 months without primary endpoint events are all treated as having 
events; (iii) best-case strategy: all treated as having no events; (iv) multiple 
imputation of missing outcome data using chained equations (MICE). 
For the primary clinical endpoint (HF rehospitalization or death), two-sided P<0.04 
will be considered statistically significant; for the second primary endpoint (quality 
improvement), two-sided P<0.01 will be considered statistically significant. Other 
endpoints will be analyzed at a two-sided 0.05 significance level (unless otherwise 
specified). Statistical analyses will be performed using SAS 9.4 and R 4.3.2. 
 

X. Ethics-Related Considerations 
10.1 Ethics Committee Review 
This protocol, written informed consent form, and materials directly related to 
subjects must be submitted to the ethics committee and approved in writing before 
formal study initiation. Investigators must submit at least annual reports to the ethics 
committee (if applicable). Investigators must notify the ethics committee in writing 
upon study termination and/or completion; investigators must promptly report any 
changes occurring during the study (e.g., revisions to the protocol and/or informed 
consent forms), and such changes must not be implemented before ethics approval 
unless required to eliminate an obvious and direct risk to subjects. In such cases, the 
ethics committee will be notified. 
10.2 Informed Consent 
In this study, subjects must not be enrolled before obtaining signed written informed 
consent. During participation, subjects will be provided with all updated versions of 
the informed consent form and written information. The informed consent form shall 
be retained as an essential clinical trial document for inspection. 
 
XI. Confidentiality Measures 
The results of this project may be published in medical journals, but we will keep 
patient information confidential in accordance with legal requirements. Unless 
required by relevant laws, patients’ personal information will not be disclosed. When 
necessary, government authorities and hospital ethics committees and relevant 
personnel may review patient records as 规定 (as stipulated). 
 
XII. Expected Study Timeline and Completion Date 
Planned enrollment period: 12 months (January 2026 to December 2026). Follow-up 
period: 12 months. Planned study completion date: March 2028. 
 
XIII. References 
1. Savarese G, Becher PM, Lund LH, Seferovic P, Rosano GMC, Coats AJS. 
Global burden of heart failure: a comprehensive and updated review of 
epidemiology. Cardiovasc Res 2023; 118(17): 3272-87. 

2. Consortium of China Heart Failure Centers, Institute of Cardiovascular Health 
in Suzhou Industrial Park, China Cardiovascular Association. Heart Failure 
Center Work Report (2021)–Current Status of Diagnosis and Treatment of 
Heart Failure Patients. Chin J Intervent Cardiol 2022; 30(5): 328-36. 
3. Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA 
Guideline for the Management of Heart Failure: A Report of the American 
College of Cardiology/American Heart Association Joint Committee on 
Clinical Practice Guidelines. Circulation 2022; 145(18): e895-e1032. 
4. McDonagh TA, Metra M, Adamo M, et al. 2023 Focused Update of the 2021 
ESC Guidelines for the diagnosis and treatment of acute and chronic heart 
failure. Eur Heart J 2023; 44(37): 3627-39. 
5. Chinese Society of Cardiology, Chinese Medical Association; Chinese 
College of Cardiovascular Physicians; Chinese Heart Failure Association; 
Editorial Board of Chinese Journal of Cardiology. China Guidelines for the 
Diagnosis and Treatment of Heart Failure 2024. Chinese Journal of 
Cardiology 2024; 52(3): 235-75. 
6. Greene SJ, Butler J, Albert NM, et al. Medical Therapy for Heart Failure With 
Reduced Ejection Fraction: The CHAMP-HF Registry. J Am Coll Cardiol 
2018; 72(4): 351-366. 
7. Sumarsono A, Xie L, Keshvani N, et al. Sex Disparities in Longitudinal Use 
and Intensification of Guideline-Directed Medical Therapy Among Patients 
With Newly Diagnosed Heart Failure With Reduced Ejection Fraction. 
Circulation 2024; 149(7): 510-520. 
8. Heidenreich PA, Hernandez AF, Yancy CW, et al. Get With The Guidelines 
Program Participation, Process of Care, and Outcome for Medicare Patients 
Hospitalized With Heart Failure. Circ Cardiovasc Qual Outcomes 2012; 5(1): 
37-43. 
9. DeVore AD, Granger BB, Fonarow GC, et al. Effect of a Hospital and 
Postdischarge Quality Improvement Intervention on Clinical Outcomes and 
Quality of Care for Patients With Heart Failure With Reduced Ejection 
Fraction: The CONNECT-HF Randomized Clinical Trial. JAMA 2021; 
326(4): 314-323. 
10. Van Spall HG, Lee SF, Xie F, et al. Effect of Patient-Centered Transitional 
Care Services on Clinical Outcomes in Patients Hospitalized for Heart Failure: 
The PACT-HF Randomized Clinical Trial. JAMA 2019; 321(8): 753-761. 
11. Cai A, Qiu W, Zhou Y, et al. Clinical characteristics and 1-year outcomes in 
hospitalized patients with heart failure with preserved ejection fraction: results 
from the China Cardiovascular Association Database-Heart Failure Center 
Registry. Eur J Heart Fail 2022; 24: 2048–62. 
12. Wang H, Li YY, Chai K, et al. Contemporary epidemiology and treatment of 
hospitalized heart failure patients in real clinical practice in China. Zhonghua 
Xin Xue Guan Bing Za Zhi 2019; 47: 865–74 (in Chinese). 
13. Wang H, Li Y, Chai K, et al. Mortality in patients admitted to hospital with 
heart failure in China: a nationwide Cardiovascular Association Database-

Heart Failure Centre Registry cohort study. Lancet Glob Health 2024; 12(4): 
e611-e622. 
 
 
 
 
 

Informed Consent Form 
Participant Information Sheet 
Protocol Title: 
China Heart Failure Center Accreditation Program (HF-CAP): A Prospective 
Multicenter Cluster Randomized Controlled Trial 
Principal Investigator at This Center: 
Jingmin Zhou 
Study Center: 
Zhongshan Hospital, Fudan University 
Sponsor: 
Zhongshan Hospital, Fudan University 
 
Dear Participant, 
You are invited to participate in the research study entitled “China Heart Failure 
Center Accreditation Program (HF-CAP): A Prospective Multicenter Cluster 
Randomized Controlled Trial.” 
Please read this informed consent form carefully and make a prudent decision about 
whether to participate in this study. 
Participation in this study is entirely voluntary. You may be considered for enrollment 
in this study only after you have signed this informed consent form. When your study 
physician or research staff discusses this informed consent form with you, you may 
ask him/her to explain any part that you do not understand. We encourage you to fully 
discuss your decision to participate in this study with your family members and 
friends before making a decision. 
You have the right to refuse to participate in this study or to withdraw from the study 
at any time without penalty or loss of benefits to which you are otherwise entitled. If 
you are currently participating in another research study, please inform your study 
physician or research staff. 
The background, purpose, procedures, and other important information of this study 
are described below. 
 
I. Background of the Study 

Heart failure (HF) represents the advanced and terminal stage of cardiovascular 
diseases and poses a serious threat to human health. It is a major public health burden 
in China and worldwide. 
Over the past decades, significant progress has been made in the treatment of heart 
failure, particularly in heart failure with reduced ejection fraction (HFrEF), where 
multiple pharmacological and device-based therapies have been proven to 
significantly improve prognosis and quality of life, driving updates in international 
heart failure guidelines. However, in real-world clinical practice, there remains a 
substantial gap between guideline-recommended therapies and actual clinical 
implementation. 
The China Heart Failure Center Accreditation Program (HF-CAP) is a nationwide 
heart failure quality improvement initiative launched in 2017 under the leadership of 
the Chinese Medical Association. Its aim is to improve the management of patients 
with heart failure. Registry data from heart failure centers indicate that during the 
development of heart failure centers, the utilization of standardized diagnostic 
techniques has increased annually, the use of guideline-recommended 
pharmacological therapies at discharge has progressively improved, and a downward 
trend in 1-year mortality after discharge has been observed. 
This project intends to evaluate the impact of the HF-CAP program on patient 
outcomes through a multicenter, prospective, cluster-randomized, controlled clinical 
trial conducted across China. 
 
II. Purpose of the Study 
1. To evaluate the effect of HF-CAP compared with routine care on 1-year 
clinical outcomes in patients with heart failure; 
2. To assess the effectiveness of HF-CAP compared with routine care in 
improving the quality of heart failure management. 
 
III. Study Procedures 
1. How many participants will take part in this study? 
Approximately 6,240 participants will be enrolled in this study, which will be 
conducted across 160 participating study centers/medical institutions. 
 
2. Study Procedures 

If you agree to participate in this study, you will be asked to sign this informed 
consent form. 
This study consists of three phases: the hospital screening phase, the randomization 
phase, and the intervention and follow-up period. 
Hospital Screening Phase 
Hospitals registered on the China Heart Failure Center platform that have 
continuously uploaded data but have not yet applied for accreditation will be 
screened. Based on hospital level and annual heart failure admission volume, 
eligibility will be assessed according to inclusion and exclusion criteria. Hospitals will 
be stratified according to hospital level, heart failure case volume, and medical care 
capacity into a Standard Version and a Primary Version. 
Hospitals meeting the inclusion criteria, without exclusion criteria, and willing to 
participate in the study will be preliminarily selected. These hospitals will apply for 
ethics approval according to the study protocol. Hospitals that obtain ethics approval 
will be formally included and proceed to the randomization phase. 
Randomization Phase 
The unit of randomization in this study is the hospital. Stratified randomization will 
be performed to ensure balance of hospital characteristics within each stratum. Both 
the Standard Version and Primary Version hospitals will be randomly assigned in a 
1:1 ratio to either the HF-CAP intervention group or the routine care group. 
Intervention and Follow-up Period 
Hospitals assigned to the HF-CAP intervention group will receive a series of HF-CAP 
management measures under the guidance of the HF-CAP Expert Committee. 
Hospitals assigned to the routine care group will not receive any additional 
intervention and will manage heart failure patients according to usual clinical practice. 
After randomization, all participating hospitals will introduce the study to every heart 
failure patient who meets the inclusion criteria and does not meet the exclusion 
criteria. Patients who provide informed consent will be considered successfully 
enrolled. 
Standard Version heart failure centers will enroll the first 10 consecutively admitted 
eligible patients each month, while Primary Version centers will enroll the first 8 
consecutively admitted eligible patients each month, based on admission order 
without selection. 

Baseline data will be collected for all enrolled patients and uploaded to the Heart 
Failure Center Electronic Data Capture (EDC) system, including: 
1. Sociodemographic characteristics: sex, age, height, weight; 
2. Socioeconomic characteristics: education level, employment status, type of 
medical insurance; 
3. Medical history: heart failure symptoms, NYHA functional class, disease 
duration, etiology, precipitating factors, comorbidities, personal history, and 
family history; 
4. Physical examination: blood pressure, heart rate, oxygen saturation, jugular 
venous distension, pulmonary rales, lower-limb edema; 
5. Diagnostic tests: electrocardiogram, echocardiography, 6-minute walk 
distance; 
6. Laboratory tests: complete blood count, liver and renal function, electrolytes, 
BNP or NT-proBNP, blood glucose, blood lipids; 
7. Medication use: heart failure medications, cardiovascular medications, and 
other medications; 
8. In-hospital outcomes. 
Follow-up visits are required at 1 week, 1 month (±7 days), 3 months (±14 days), 
and 12 months (±28 days) after discharge, with data uploaded to the Heart Failure 
Center EDC system. 
The 1-week follow-up will be conducted by telephone only, collecting information on 
heart failure rehospitalization and survival status. 
Follow-up visits at 1 month, 3 months, and 12 months should preferably be conducted 
as on-site visits. Telephone follow-up is acceptable if an on-site visit cannot be 
completed. Follow-up assessments include symptom evaluation, physical signs, 
NYHA functional class, vital signs (blood pressure, heart rate), body weight, 
laboratory tests (complete blood count, liver and renal function, electrolytes, BNP or 
NT-proBNP), electrocardiogram, medication records, and endpoint events. 
Echocardiography and 6-minute walk tests will be performed at the 3-month and 12-
month follow-up visits. 
All examinations conducted during the study period are recommended routine 
assessments according to current heart failure guidelines. No additional examinations 
are required specifically for this study. 
 
3. How long will this study last? 
The overall study is planned to last 27 months. Your individual participation in this 
study will last approximately 12 months. 

You may choose to withdraw from the study at any time without losing any benefits 
to which you are otherwise entitled. If you decide to withdraw during the study, we 
encourage you to discuss your decision with your physician. If you experience a 
serious adverse event or if your study physician believes that continued participation 
is not in your best interest, he/she may decide to withdraw you from the study. The 
sponsor or regulatory authorities may also terminate the study during the study period. 
Your withdrawal will not affect your standard medical care or rights. 
 
4. Biological Specimens 
No biological specimens will be collected in this study. 
 
IV. Risks and Benefits 
1. What are the risks of participating in this study? 
The interventions involved in this study are based on current domestic and 
international heart failure guideline recommendations, and their risks are comparable 
to those of routine clinical treatment. There may also be risks related to information 
security. We will make every effort to protect your information from unauthorized 
disclosure and to safeguard your personal privacy within the limits permitted by law. 
If you experience any discomfort, changes in your condition, or unexpected events 
during the study, whether or not related to the study, you should promptly inform your 
study physician. 
You will be required to attend follow-up visits and undergo certain examinations 
during the study, which may take up some of your time and may cause inconvenience. 
2. What are the benefits of participating in this study? 
Direct benefits: By participating in this study, you may potentially receive optimized 
treatment strategies through the Heart Failure Center Accreditation Program and 
experience improvement in your heart failure condition; however, such benefits 
cannot be guaranteed. 
Potential benefits: The information obtained from your participation may benefit you 
or other patients with similar conditions in the future. 
 
V. Alternative Treatment Options 

In addition to participating in this study, you may receive routine medical care 
provided by your physician, including regular follow-up visits and adjustment of heart 
failure medications according to standard clinical practice. 
Please discuss these and other possible options with your physician. 
 
VI. Confidentiality of Personal Information 
During the study, the research team may need access to your medical history and 
necessary past medical records and test results for research purposes. By signing this 
informed consent form, you authorize the research team to contact other healthcare 
providers involved in your care to obtain necessary medical information. 
Only members of the research team will have access to your identifiable medical 
information. Without violating confidentiality principles and relevant regulations, 
authorized investigators, ethics committees, and regulatory authorities may review 
your original medical records to verify clinical trial data. 
Your personal identifying information (such as name and contact details) will be 
coded to prevent identification. If study results are published in medical journals or 
presented at scientific conferences, no information that could identify you will be 
disclosed. 
You may withdraw your authorization for the use and sharing of your personal 
information at any time by contacting your study physician. If you do so, you will no 
longer be able to participate in the study. No new identifiable health data will be 
collected thereafter; however, previously collected data may continue to be used and 
shared as described in this consent form. 
To ensure scientific integrity, you may not be able to access certain study-related 
records before the study is completed. After study completion, you may request 
access to your health data collected during the study and request correction of any 
errors. 
All personal information and study data collected during this study will be coded and 
stored at Zhongshan Hospital, Fudan University, and destroyed after three years. Your 
information will not be used for future research beyond this study. 
 
VII. Disclosure of Study Results 
Overall study results (excluding personal identifiable information) will be described 
after study completion at . You may search for the study using relevant keywords. 

 
VIII. Study Costs and Compensation 
1. Study-related medications/devices and examinations 
Electrocardiograms, echocardiography, laboratory tests, and medications during the 
study are part of routine clinical care. The study does not incur additional costs and 
does not provide free medications or examinations. Treatment and examinations for 
other concurrent conditions are not covered. 
2. Compensation for participation 
As there are no additional examinations or medical expenses associated with 
participation, follow-up management support will be provided, and no additional 
compensation will be offered. 
3. Compensation for injury 
This study does not involve investigational drugs or devices. All medical care follows 
guideline recommendations, and no additional risk of injury is anticipated. 
 
IX. Participant Rights and Responsibilities 
1. Your Rights 
Your participation is voluntary. Refusal to participate will not affect your access to 
standard medical care. You may withdraw from the study at any time without 
discrimination or unfair treatment, and your medical care and rights will not be 
affected. If new information arises that may affect your rights or safety, an updated 
informed consent form will be provided for re-consent. 
2. Participant Responsibilities 
As a participant, you are required to provide truthful information regarding your 
medical history and current health status; report any discomfort experienced during 
the study; refrain from restricted medications or foods as instructed; and inform the 
study physician if you are participating or have recently participated in other studies. 
 
X. Contact Information 

If important new information arises during the study that may affect your willingness 
to continue participation, your physician will inform you promptly. If you have 
questions about your study data or wish to learn about the study findings after 
completion, you may contact Xu Yamei at 139-1713-3371 at any time. 
This study has been reviewed and approved by the Ethics Committee. If you have any 
concerns regarding your rights or wish to provide comments or complaints related to 
the study, please contact the Medical Ethics Committee of Zhongshan Hospital, 
Fudan University: 
Tel: 021-3158-7871 
Email: ec@zs-hospital.sh.cn 
 
Participant Signature Page 
Informed Consent Statement 
I have been informed of the purpose, background, procedures, risks, and benefits of 
this study. I have had sufficient time and opportunity to ask questions, and all my 
questions have been answered satisfactorily. I agree to participate in this study. 
I have been informed of whom to contact if I have questions, concerns, suggestions, 
or wish to obtain further information or assist with the study. 
I understand that I may choose not to participate or may withdraw from the study at 
any time without providing a reason. 
I understand that if my condition worsens, if I experience a serious adverse event, or 
if my study physician determines that continued participation is not in my best 
interest, I may be withdrawn from the study. The sponsor or regulatory authorities 
may also terminate the study during the study period without my consent. In such 
cases, I will be informed promptly and alternative options will be discussed. 
I will receive a copy of this informed consent form signed by myself and the 
investigator. 
I understand that participation in this study requires the use of my personal 
information, and I consent to the use and processing of my personal information for 
the purposes described in this informed consent form. 
☐ Agree  ☐ Disagree (not eligible to participate in this study) 
Participant Signature: _______________________  Date: ___________ 

Legal Representative Signature: _______________ 
Relationship to Participant (  )  Date: ___________ 
(Applicable when the participant lacks or has limited capacity for civil conduct) 
Impartial Witness Signature: _______________  Date: ___________ 
(Applicable when the participant is unable to read this informed consent form) 
Investigator Signature: ______________________  Date: ___________