Clinical trial NCT05583773: SHengXIaN-QuYu DEcoction in Heart Failure With Reduced and Mildly Reduced Ejection Fraction
Official title: Effects of "ShengXian-QuYu Decoction" on Quality of Life, Symptoms, and Biomarkers in Heart Failure Patients With Reduced and Mildly Reduced Ejection Fraction: a Pragmatic, Nationwide, Multicenter, Parallel Group, Randomized, Double-Blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Heart Failure
Keywords: ShengXian-QuYu Decoction
Heart failure with reduced ejection fraction
Heart failure with mildly reduced ejection fraction
Quality of life
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 336
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to conduct a multicenter, randomized clinical trial to evaluate the effect of "ShengXian-QuYu Decoction" on quality of life , symptoms, and biomarkers in heart failure patients with reduced and mildly reduced ejection fraction.

Detailed description: This is a pragmatic, nationwide, multicenter, parallel group, randomized, double-blind, placebo-controlled study in patients with heart failure with reduced and mildly ejection fraction, evaluating the effect of "ShengXian-QuYu Decoction" versus placebo, given twice daily in addition to background regional standard of care. The effect of "ShengXian-QuYu Decoction"on quality of life, symptoms and biomarkers will be evaluated.

The primary and secondary endpoints will be examined in subgroups determined by baseline variables reflecting demography, heart failure characteristics, Traditional Chinese Medicine syndrome type, diabetes status, kidney function, left ventricular ejection fraction, natriuretic peptide, and additional co-morbidities, concomitant medications, and others.

Eligibility criteria: Inclusion Criteria:

1. Male or female, aged ≥18 years at the time of consent.
2. Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV).
3. LVEF \<50%.
4. NT-proBNP \>600 pg/ml or BNP ≥150 pg/ml (or if hospitalized for heart failure within the previous 12 months, NT-proBNP ≥400 pg/ml or BNP ≥100 pg/ml) at enrolment.
5. Provision of signed informed consent prior to any study specific procedures.

Exclusion Criteria:

1. Current acute decompensated HF or hospitalization due to decompensated HF, ACS, stroke or transient ischemic attack (TIA), coronary revascularization (percutaneous coronary intervention \[PCI\] or coronary artery bypass grafting \[CABG\]) or valvular repair/replacement, or other major cardiovascular surgery within 4 weeks prior to enrolment.
2. Uncontrolled severe arrhythmia.
3. Planned to undergo heart transplantation or device implantation.
4. Hepatic impairment aspartate transaminase \[AST\] or alanine transaminase \[ALT\] \>3x the upper limit of normal \[ULN\]; or total bilirubin \>2x ULN at time of enrolment).
5. Severe infection.
6. eGFR \<30 mL/min/1.73 m\^2 by CKD-EPI.
7. Active malignancy requiring treatment at the time of visit 1.
8. Women of child-bearing potential who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator OR women who have a positive pregnancy test at enrolment or randomization OR women who are breast-feeding.
9. Any condition outside the CV and renal disease area, such as but not limited to malignancy, with a life expectancy of less than 1 years based on investigator's clinical judgement.
10. Systolic blood pressure \< 90 mmHg, or systolic blood pressure ≥ 180 mmHg, or diastolic blood pressure ≥ 110 mmHg on 2 consecutive measurements.
11. Heart failure due to infiltrative cardiomyopathies(cardiac amyloidosis, etc.), fulminant myocarditis, constrictive pericarditis.
12. Participation in another clinical study.
13. Inability of the patient, in the opinion of the investigator, to understand and/or comply with study medications, procedures and/or follow-up OR any conditions that, in the opinion of the investigator, may render the patient unable to complete the study.

Primary outcomes:
measure: Change From Baseline in the KCCQ Clinical Summary Score
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Change From Baseline in the Traditional Chinese Medicine Syndrome Score Scale (TCMSSS)
timeFrame: Up to 12 weeks
measure: Change in Exercise Capacity as Measured by the 6-Minutes-Walking-Test (6MWT) Distance
timeFrame: Up to 12 weeks
measure: Change in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
timeFrame: Up to 12 weeks
measure: Change in Left Ventricular Systolic Function
timeFrame: Up to 12 weeks
measure: Change in Left Ventricular End-Diastolic Diameter
timeFrame: Up to 12 weeks
measure: Change in Left Ventricular End-Systolic Diameter
timeFrame: Up to 12 weeks
measure: Change in Estimated Glomerular Filtration Rate from Baseline
timeFrame: Up to 12 weeks
measure: Change From Baseline in the KCCQ Clinical Summary Score
timeFrame: Up to 26 weeks
measure: Change From Baseline in the Traditional Chinese Medicine Syndrome Score Scale (TCMSSS)
timeFrame: Up to 26 weeks
Other outcomes:
measure: Subjects Included in the Composite Endpoint of Cardiovascular Death and Worsening Heart Failure
timeFrame: Up to 12 weeks
measure: Subjects Included in the Composite Endpoint of Cardiovascular Death and Worsening Heart Failure
timeFrame: Up to 26 weeks
measure: Renal Composite Endpoint
timeFrame: Up to 12 weeks
measure: Renal Composite Endpoint
timeFrame: Up to 26 weeks
measure: Liver Injury
timeFrame: Up to 12 weeks
measure: Liver Injury
timeFrame: Up to 26 weeks
measure: Bleeding Events
timeFrame: Up to 12 weeks
measure: Bleeding Events
timeFrame: Up to 26 weeks
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Fengtai Hospital of Integrated Traditional Chinese and Western Medicine
state: Beijing
city: Beijing
country: China
facility: Dongcheng District First People's Hospital
state: Beijing
city: Beijing
country: China
facility: Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
state: Beijing
city: Beijing
country: China
facility: Huairou District Traditional Chinese Medicine Hospital of Beijing
state: Beijing
city: Beijing
country: China
facility: Beijing Changping Nankou Hospital
state: Beijing
city: Beijing
country: China
facility: Changping District Traditional Chinese Medicine Hospital
state: Beijing
city: Baoding
country: China
facility: Tang County Hospital of Traditional Chinese Medicine
state: Hebei
city: Qinhuangdao
country: China
facility: Funing Hospital of Traditional Chinese Medicine
state: Hebei
city: Gongyi
country: China
facility: Gongyi City Public Hospital of TCM
state: Henan
city: Yangzhou
country: China
facility: Yangzhou Hospital of Traditional Chinese Medicine
state: Jiangsu
city: Jining
country: China
facility: Jining Hospital of Traditional Chinese Medicine
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Changzhi
country: China
facility: The Affiliated Hospital of Changzhi Institute of Traditional Chinese Medicine
state: Shanxi
city: Changzhi
country: China
facility: Changzhi Medical College Affiliated Heji Hospital
state: Shanxi
city: Changzhi
country: China
facility: Changzhi Hospital of Traditional Chinese Medicine
state: Shanxi
city: Chengdu
country: China
facility: Chengdu Integrated TCM and Western Medicine Hospital
state: Sichuan
city: Tianjin
country: China
facility: Jixian Chinese Traditional Hospital
state: Tianjin
city: Bayan Gol Autonomous Prefecture
country: China
facility: Korla Hospital of Traditional Chinese Medicine
state: Xinjiang Uygur Autonomous Region
city: Changji Hui Autonomous Prefecture
country: China
facility: Changji Hospital of Traditional Chinese Medicine
state: Xinjiang Uygur Autonomous Region
city: Ili Kazakh Autonomous Prefecture
country: China
facility: Gulja Hospital of Traditional Chinese Medicine
state: Xinjiang Uygur Autonomous Region
city: Ili Kazakh Autonomous Prefecture
country: China
facility: Zhaosu Hospital of Traditional Chinese Medicine
state: Xinjiang Uygur Autonomous Region
city: Ili Kazakh Autonomous Prefecture
country: China
facility: Xinyuan Traditional Chinese Medicine Hospital
state: Xinjiang Uygur Autonomous Region
city: Urumqi
country: China
facility: Urumqi Hospital of Traditional Chinese Medicine
state: Xinjiang
city: Linhai
country: China
facility: Linhai Hospital of Traditional Chinese Medicine
state: Zhejiang
Study officials:
References: