Clinical trial NCT06099028: Heart Failure Treatment Pattern Analysis of HF Patients in HF Centers and Non-HF Centers in China
Official title: Heart Failure Treatment Pattern Analysis of HF Patients in HF Centers and Non-HF Centers in China: a Retrospective Database-based Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: China Cardiovascular Association
name: AstraZeneca
First posted: 2023-10-25
Enrollment: 22500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include HF patients extracted from the HF centers Database. The enrolment of HF cases was via the consecutive sampling. In this study, the study time frame is from 2021.09 to 2023.03. The index date will be defined as the discharge date after the first HF admission (inpatient) record shown in the database, (i.e., the discharge date is the date entry into the HF centers Database). Given that previous treatment condition of these patients before the enrolment in this database is unknown, the baseline information was only collected at the index date. Patient follow-ups were scheduled at 1 month, 3 months and 12 months after the first discharge. The window of follow-up was set for ±14 days.

Brief summary: This is a retrospective, researcher-initiated, database-based study that will retrospectively observe the treatment and medication patterns of about 22,500 patients with heart failure from 25 heart failure centers and 25 non-heart failure centers in the database of heart failure center. The proportion of patients with heart failure treatment drugs reaching the target dose recommended in the guidelines and discontinuation rate will be observed at 1 month, 3 months and 12 months follow up time point. The purpose of this study is to illustrate the current HF treatment status in HF center hospitals and non-HF center hospitals, which may provide insights for improving the clinical practice of heart failure treatment in China, and promote the standardization of heart failure treatment in China.


Eligibility criteria: Inclusion Criteria:

* An index HF diagnosis date in the records
* Age ≥ 18 years old at initial diagnosis date
* HF patients baseline characteristic record

Primary outcomes:
measure: Number of GDMT drugs (classified as RAASi (including ARNI), beta blockers, MRA and SGLT2i)
timeFrame: At baseline and at 1 month, 3 month, 12 month follow-up time point
measure: Use rates of GDMT drugs
timeFrame: At baseline and at 1 month, 3 month, 12 month follow-up time point
Secondary outcomes:
measure: The proportion of patients using 2 types of GDMT drugs
timeFrame: At baseline and at 1 month, 3 month, 12 month follow-up time point
measure: The proportion of patients using 3 types of GDMT drugs
timeFrame: At baseline and at 1 month, 3 month, 12 month follow-up time point
measure: The proportion of patients using 4 types of GDMT drugs
timeFrame: At baseline and at 1 month, 3 month, 12 month follow-up time point
measure: The proportion of patients with each GDMT drug in the target dose
timeFrame: at 1 month, 3 month, 12 month follow-up time point
measure: Discontinuation rate of each GDMT drug
timeFrame: at 1 month, 3 month, 12 month follow-up time point
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Cardiology, Peking University First Hospital
Study officials:
affiliation: Peking University First Hospital
name: Huo Yong, MD.
role: PRINCIPAL_INVESTIGATOR
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