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 at the Day 11 end-of-treatment visit after the 10-day treatment course. 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 Day 1 before the first infusion and on Day 11 at the end-of-treatment visit for exploratory transcriptomic, proteomic, and metabolomic analyses.
Age 40 to 80 years, inclusive, of any sex.
Confirmed coronary heart disease or chronic coronary syndrome according to the protocol-defined criteria, supported by at least one verifiable item such as prior myocardial infarction, prior PCI or CABG, at least 50% stenosis in a major epicardial coronary artery on angiography or coronary CT angiography, FFR of 0.80 or less, iFR of 0.89 or less, or imaging evidence of prior ischemic infarction or scar with corresponding coronary atherosclerosis.
Heart failure judged to be caused primarily by coronary heart disease, with objective evidence supporting an ischemic cause and no more likely major nonischemic cause.
A documented diagnosis of chronic heart failure for at least 3 months, or verifiable persistent heart-failure treatment with structural or functional cardiac abnormality; and stable chronic heart failure with reduced ejection fraction at Day 0, defined by LVEF of 40% or less, NT-proBNP of at least 450 pg/mL, and NYHA class II or III.
Acute heart failure, acute decompensation of chronic heart failure, cardiogenic shock, malignant arrhythmia, acute respiratory failure, acute pulmonary edema, need for mechanical ventilation or mechanical circulatory support, or another critical condition requiring immediate rescue treatment.
Acute coronary syndrome or acute myocardial infarction within 1 month before enrollment if the investigator determines that it will materially affect efficacy, safety, or omics assessments.
PCI or CABG within 3 months before screening; CRT implantation or upgrade within 6 months before screening; or a definite plan for PCI, CABG, or CRT implantation or upgrade within the next 6 months. Prior CRT is not an absolute exclusion if it was performed at least 6 months earlier, device settings and clinical status are stable, and no major upgrade or parameter change is planned.
NYHA class IV, clinical instability, or inability to safely complete the short-term study procedures.
Single group
Yiqi Fumai Lyophilized Injection(YQFM)
DrugEight 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
Other interventionParticipants 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.
Percentage of Participants With a KCCQ-CSS Response at Day 11
A responder generally has an increase of at least 5 points in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) from baseline to Day 11.Death, heart-failure rehospitalization, major rescue therapy, inability to complete the questionnaire because of worsening heart failure, or a missing Day 11 primary assessment in the full analysis set is counted as nonresponse. The official Simplified Chinese KCCQ-23 is administered independently and CSS is derived centrally. The prespecified performance goal is p0=50%; with n=100, at least 59 responders are required by the one-sided exact binomial rule.
Percentage of Participants With an NT-proBNP Response at Day 11
A responder has a decrease of at least 30% in NT-proBNP from baseline, calculated as \[(baseline value - Day 11 value) / baseline value\] x 100. The primary analysis uses paired central-laboratory results obtained with the same specimen type, platform, unit, calibration, and quality-control procedures. Death, heart-failure rehospitalization, major rescue therapy, inability to complete assessment because of worsening heart failure, or a missing Day 11 primary assessment in the full analysis set is counted as nonresponse. The prespecified performance goal is p0=45%; with n=100, at least 54 responders are required after the KCCQ-CSS test has passed.
Change From Baseline in KCCQ-CSS
KCCQ-CSS is derived centrally from the official Simplified Chinese KCCQ-23. Change from baseline is summarized as a continuous measure, together with the proportions achieving increases of at least 5, 10, and 15 points. Day 30 is the key supportive time point and Day 90 assesses persistence.
Change and Percent Change From Baseline in NT-proBNP
Absolute change, percent change, and the proportion with a decrease of at least 30% are summarized. Day 30 is the key supportive time point. BNP and NT-proBNP values are not combined.
Percentage of Participants With a Clinical Response in Qi and Yin Deficiency Syndrome
The syndrome-score reduction rate is calculated as \[(baseline score - follow-up score) / baseline score\] x 100. A reduction of at least 70% is classified as markedly effective, 30% to 69% as effective, and less than 30% as ineffective. Total response equals markedly effective plus effective.
Change From Baseline in Left Ventricular Ejection Fraction
Left ventricular ejection fraction is measured by the modified biplane Simpson method. Original DICOM images are centrally reviewed by readers blinded to visit time and clinical outcomes; the central value is the supportive primary result for this measure.
Change From Baseline in EQ-5D-5L Utility Value
EQ-5D-5L item-level responses are converted centrally to utility values using the Chinese population value set.
Quality-Adjusted Life-Years Through Day 90
Individual quality-adjusted life-years are estimated from EQ-5D-5L utility values using the area-under-the-curve method for the Day 0-Day 10, Day 0-Day 30, and Day 0-Day 90 intervals.
Incidence of Heart-Failure Rehospitalization
The proportion of participants with at least one heart-failure-related rehospitalization is recorded, together with the number and duration of rehospitalizations.
Incidence of Major Adverse Cardiovascular Events
Major adverse cardiovascular events are recorded according to the prespecified clinical-event definitions in the statistical analysis plan.
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