ShengXian-QuYu Decoction: Specification: 30ml/bag, given twice daily, per oral use.
Placebo: Placebo matching ShengXian-QuYu Decoction, 30ml/bag, given twice daily, per oral use.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)
Change From Baseline in the KCCQ Clinical Summary Score — Up to 12 weeks KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. KCCQ-clinical summary score was average of domains- physical limitation and total symptoms (average of symptom frequency and symptom burden), and transformed to a single score which ranged from 0 (worst) -100 (the best possible status), where the higher score reflected better health status.
Trial sites (26)
Facility
City
Region
Status
China-Japan Friendship Hospital
Beijing
Beijing Municipality
Recruiting
Peking University People's Hospital
Beijing
Beijing Municipality
Recruiting
Beijing Fengtai Hospital of Integrated Traditional Chinese and Western Medicine
Beijing
Beijing Municipality
Recruiting
Dongcheng District First People's Hospital
Beijing
Beijing Municipality
Recruiting
Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
Beijing
Beijing Municipality
Recruiting
Huairou District Traditional Chinese Medicine Hospital of Beijing
Beijing
Beijing Municipality
Recruiting
Beijing Changping Nankou Hospital
Beijing
Beijing Municipality
Recruiting
Changping District Traditional Chinese Medicine Hospital
Beijing
Beijing Municipality
Recruiting
Tang County Hospital of Traditional Chinese Medicine
Baoding
Hebei
Recruiting
Funing Hospital of Traditional Chinese Medicine
Qinhuangdao
Hebei
Recruiting
Gongyi City Public Hospital of TCM
Gongyi
Henan
Recruiting
Yangzhou Hospital of Traditional Chinese Medicine
Yangzhou
Jiangsu
Recruiting
Jining Hospital of Traditional Chinese Medicine
Jining
Shandong
Recruiting
The Affiliated Hospital of Qingdao University
Qingdao
Shandong
Recruiting
The Affiliated Hospital of Changzhi Institute of Traditional Chinese Medicine
Changzhi
Shanxi
Recruiting
Changzhi Medical College Affiliated Heji Hospital
Changzhi
Shanxi
Recruiting
Changzhi Hospital of Traditional Chinese Medicine
Changzhi
Shanxi
Recruiting
Chengdu Integrated TCM and Western Medicine Hospital
Chengdu
Sichuan
Recruiting
Jixian Chinese Traditional Hospital
Tianjin
Tianjin Municipality
Recruiting
Urumqi Hospital of Traditional Chinese Medicine
Ürümqi
Xinjiang
Recruiting
Korla Hospital of Traditional Chinese Medicine
Bayan Gol Autonomous Prefecture
Xinjiang Uygur Autonomous Region
Recruiting
Changji Hospital of Traditional Chinese Medicine
Changji Hui Autonomous Prefecture
Xinjiang Uygur Autonomous Region
Recruiting
Gulja Hospital of Traditional Chinese Medicine
Ili Kazakh Autonomous Prefecture
Xinjiang Uygur Autonomous Region
Recruiting
Zhaosu Hospital of Traditional Chinese Medicine
Ili Kazakh Autonomous Prefecture
Xinjiang Uygur Autonomous Region
Recruiting
Xinyuan Traditional Chinese Medicine Hospital
Ili Kazakh Autonomous Prefecture
Xinjiang Uygur Autonomous Region
Recruiting
Linhai Hospital of Traditional Chinese Medicine
Linhai
Zhejiang
Recruiting
More China-Japan Friendship Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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