Yiqi Fumai Lyophilized Injection for Chronic Heart Failure Caused by Coronary Heart Disease
Condition(s) studied
Investigational drug(s) / intervention(s)
Yiqi Fumai Lyophilized Injection(YQFM): Eight vials (0.65 g per vial; total 5.2 g) are diluted in 250 mL of 0.9% sodium chloride and administered by intravenous infusion once daily at 35 to 40 drops per minute for a planned 10 consecutive days. The product is manufactured by Tianjin Tasly Pride Pharmaceutical Co., Ltd. and is approved in China under NMPA approval number Z20060463. Each infusion is preceded by verification of indication, allergy history, vital signs, volume status, diluent, compatibility, product appearance, expiry date, and emergency readiness. Symptoms, heart rate, blood pressure, respiratory rate, and oxygen saturation are monitored at 15 minutes, 30 minutes, and at the end of infusion.
Stable Guideline-Directed Medical Therapy: Participants continue guideline-directed medical therapy appropriate to their clinical condition. Core background therapies should generally have been stable for at least 2 weeks before Day 0. Any modification required for safety or clinical deterioration takes priority and is fully documented, including daily doses of ARNI/ACEI/ARB, beta-blockers, mineralocorticoid receptor antagonists, SGLT2 inhibitors, loop diuretics, and other heart-failure therapies.
Study summary
This study will evaluate whether adding Yiqi Fumai lyophilized injection to stable guideline-directed treatment improves symptoms, physical limitations, and NT-proBNP in adults with stable chronic heart failure caused by coronary heart disease. About 100 participants at four hospitals in China will receive 8 vials of Yiqi Fumai once daily by intravenous infusion for a planned 10 days. The two main outcomes will be the proportion of participants with at least a 5-point improvement in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score and the proportion with at least a 30% decrease in NT-proBNP at the Day 11 end-of-treatment visit after the 10-day treatment course. Participants will be followed through Day 90 for heart function, exercise capacity, quality of life, safety, healthcare use, costs, and clinical events. A randomly selected subgroup of 50 participants will provide paired blood samples on Day 1 before the first infusion and on Day 11 at the end-of-treatment visit for exploratory transcriptomic, proteomic, and metabolomic analyses.
Eligibility
Primary outcome measure(s)
- Percentage of Participants With a KCCQ-CSS Response at Day 11 — Baseline (Day 1 before the first infusion) to Day 11, 24 +/- 4 hours after initiation of the 10th infusion (no Day 11 infusion)
A responder generally has an increase of at least 5 points in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) from baseline to Day 11.Death, heart-failure rehospitalization, major rescue therapy, inability to complete the questionnaire because of worsening heart failure, or a missing Day 11 primary assessment in the full analysis set is counted as nonresponse. The official Simplified Chinese KCCQ-23 is administered independently and CSS is derived centrally. The prespecified performance goal is p0=50%; with n=100, at least 59 responders are required by the one-sided exact binomial rule. - Percentage of Participants With an NT-proBNP Response at Day 11 — Baseline (Day 1 before the first infusion) to Day 11, 24 +/- 4 hours after initiation of the 10th infusion (no Day 11 infusion)
A responder has a decrease of at least 30% in NT-proBNP from baseline, calculated as \[(baseline value - Day 11 value) / baseline value\] x 100. The primary analysis uses paired central-laboratory results obtained with the same specimen type, platform, unit, calibration, and quality-control procedures. Death, heart-failure rehospitalization, major rescue therapy, inability to complete assessment because of worsening heart failure, or a missing Day 11 primary assessment in the full analysis set is counted as nonresponse. The prespecified performance goal is p0=45%; with n=100, at least 54 responders are required after the KCCQ-CSS test has passed.
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| Guangdong Provincial Hospital of Chinese Medicine | Guangzhou | Guangdong | |
| The First Affiliated Hospital of Henan University of Chinese Medicine | Zhengzhou | Henan | |
| Guang'anmen Hospital Jinan Hospital, China Academy of Chinese Medical Sciences | Jinan | Shandong | |
| The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine | Tianjin | Tianjin Municipality |
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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 NCT07803471 on ClinicalTrials.gov ↗ ← All trials in China