Yiqi Fumai Lyophilized Injection Cohort Study Protocol Aims to Assess Exercise Tolerance in Chronic Heart Failure

Chronic heart failure (CHF) is a debilitating condition marked by high mortality and significantly reduced quality of life due to diminished exercise tolerance. Current guideline-directed medical therapies often fall short in fully restoring functional capacity. Yiqi Fumai lyophilized injection (YQFM), a Traditional Chinese Medicine, is recommended in Chinese guidelines for heart failure, but robust evidence specifically on its efficacy for improving exercise tolerance remains insufficient. This study aims to address this critical evidence gap.

This prospective, observational cohort study protocol will enroll 216 hospitalized patients with CHF (NYHA functional classes II-IV). Participants are divided into a YQFM group (n=144) and a non-YQFM group (n=72) at a 2:1 ratio, reflecting real-world clinical practice. Both groups receive standard guideline-directed medical therapy, with the YQFM group additionally receiving a 10-day YQFM exposure. The primary outcome is change in metabolic equivalents via Veterans Specific Activity Questionnaire. Secondary outcomes include 6-minute walk distance, Kansas City Cardiomyopathy Questionnaire score, NYHA functional class, N-terminal pro-B-type natriuretic peptide levels, and echocardiographic parameters.

This abstract describes a study protocol, and as such, no results are available yet. Patient recruitment for all 216 participants was completed by December 2025, following the registration of the first patient in June 2024. Data cleaning and statistical analysis commenced in January 2026, with final results anticipated thereafter. Therefore, specific findings regarding the efficacy of Yiqi Fumai lyophilized injection on exercise tolerance in CHF patients are pending publication.