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NOT YET RECRUITING
NCT07803471
NA

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

Sponsor: China Academy of Chinese Medical Sciences

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

OTHER

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