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Clinical Trials in China / NCT05583773
Recruiting Phase 4

SHengXIaN-QuYu DEcoction in Heart Failure With Reduced and Mildly Reduced Ejection Fraction

NCT05583773 · tracked via the Priya Life Science China tracker
Sponsor
China-Japan Friendship Hospital
Phase
Phase 4
Started
2023-03-29
Last updated
2025-04-08

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

ShengXian-QuYu DecoctionPlacebo

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)

Trial sites (26)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT05583773 on ClinicalTrials.gov ↗ ← All trials in China