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Yiqi Fumai Lyophilized Injection for Chronic Heart Failure Caused by Coronary Heart Disease
Sponsor: China Academy of Chinese Medical Sciences
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 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.
Official title: A Dual-Perspective, Multi-Method Integrated Pharmacoeconomic Evaluation of Yiqi Fumai Lyophilized Injection for NYHA Class II or III Chronic Left Ventricular Dysfunction Due to Coronary Heart Disease in Patients With Qi and Yin Deficiency Syndrome: A Multicenter, Prospective, Open-Label, Single-Arm Performance-Goal Study
Key Details
Gender
All
Age Range
40 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-09
Completion Date
2027-10
Last Updated
2026-09-03
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (4)
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, China
The First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan, China
Guang'anmen Hospital Jinan Hospital, China Academy of Chinese Medical Sciences
Jinan, Shandong, China
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, China