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Yiqi Fumai Lyophilized Injection for Chronic Heart Failure Caused by Coronary Heart Disease

StatusNot Yet Recruiting
PhaseNot applicable
Started2026-09
View on ClinicalTrials.gov ↗
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 by Day 10 before that day's infusion. 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 Days 0 and 10 for exploratory transcriptomic, proteomic, and metabolomic analyses.
Trial Details
NCT Number NCT07803471
Lead Sponsor China Academy of Chinese Medical Sciences
Conditions Chronic Heart Failure, Heart Failure With Reduced Ejection Fraction (HFrEF), Coronary Heart Disease (CHD)
Enrollment 100 participants
Start Date 2026-09
Primary Completion 2027-07 (estimated)
Study Completion 2027-10 (estimated)
Updated on ClinicalTrials.gov 2026-09-03