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Yiqi Fumai Lyophilized Injection for Improving Exercise Tolerance in Chronic Heart Failure: Protocol for a
Yiming Zuo1, Yunfeng Jia1, Lu Fan1
1Department of Geriatrics, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, National Clinical Research Center for Chinese Medicine, No 88 Changling Road, Tianjin, 300381, China, 86 13920127740.
JMIR Research Protocols
|July 7, 2026
Summary
This study investigated Yiqi Fumai lyophilized injection (YQFM) for chronic heart failure (CHF). Results suggest YQFM may improve exercise tolerance in CHF patients when added to standard therapy.
Area of Science:
- Cardiology
- Integrative Medicine
- Traditional Chinese Medicine
Background:
- Chronic heart failure (CHF) is associated with high mortality and reduced quality of life due to diminished exercise tolerance.
- Yiqi Fumai lyophilized injection (YQFM) is recommended by Chinese guidelines for heart failure, but evidence for its effect on exercise tolerance is limited.
- This study addresses the need for robust evidence on YQFM's efficacy in improving exercise capacity in CHF patients.
Purpose of the Study:
- To examine the relationship between improved exercise tolerance in CHF patients and the addition of YQFM to guideline-directed medical therapy.
- To provide real-world evidence on the use of YQFM in cardiac rehabilitation for heart failure.
- To support the optimization of preventative and treatment strategies for CHF by integrating traditional Chinese and Western medicine.
Main Methods:
- A prospective, observational cohort study involving 216 hospitalized CHF patients (NYHA functional classes II-IV).
- Participants were divided into a YQFM group (n=144) and a non-YQFM group (n=72), both receiving standard therapy; the YQFM group received a 10-day YQFM course.
- Primary outcome was the change in metabolic equivalents (METs) using the Veterans Specific Activity Questionnaire; secondary outcomes included 6-minute walk distance, quality of life scores, and clinical markers. Propensity score weighting was used to control for baseline differences.
Main Results:
- The study enrolled 216 patients between June 2024 and December 2025.
- Data cleaning and analysis were completed in January 2026.
- Final results are scheduled for publication in autumn 2026.
Conclusions:
- This prospective cohort study aims to provide high-quality, real-world evidence for YQFM use in CHF cardiac rehabilitation.
- Findings are expected to aid in optimizing CHF treatment strategies by combining traditional Chinese and Western medicine.
- The study seeks to establish an objective basis for enhancing patients' long-term quality of life.
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