Yiqi Fumai Lyophilized Injection(YQFM) / Heart Failure With Reduced Ejection Fraction (hfref) / Stable Guideline-Directed Medical Therapy · Interventional Study

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

ClinicalTrials.gov · September 3, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned but not-yet-recruiting interventional trial of Yiqi Fumai lyophilized injection added to standard care in 100 adults with chronic heart failure and reduced ejection fraction caused by coronary heart disease. No results are available; the registry record describes only the protocol, planned endpoints (KCCQ-CSS response and NT-proBNP reduction by Day 10), and exploratory biomarker sampling in a subgroup.

What was studied

Interventional, Single Group, Open label, Treatment purpose. Chronic Heart Failure, Heart Failure With Reduced Ejection Fraction (HFrEF), Coronary Heart Disease (CHD); age from 40 Years; to 80 Years. Intervention: Yiqi Fumai Lyophilized Injection Plus Guideline-Directed Me…. Compared with: Stable guideline-directed medical therapy alone. n = 100. 4 sites: China.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

This study does not yet provide clinical evidence. Once results are published, outcomes on symptom burden (KCCQ-CSS) and neurohormonal response (NT-proBNP) will inform whether adding this herbal injection to guideline-directed medical therapy is beneficial in this population.

Plain-language summary

This is a trial registration for a planned interventional study with no results reported; enrollment has not yet begun, making it an early-stage, unexecuted protocol.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Percentage of Participants With a KCCQ-CSS Response at Day 10 (assessed at Baseline (Day 0) to Day 10 before the Day 10 infusion); Percentage of Participants With an NT-proBNP Response at Day 10 (assessed at Baseline (Day 0) to Day 10 before the Day 10 infusion)

DesignInterventional, Single Group, Open label, Treatment purpose

PopulationChronic Heart Failure, Heart Failure With Reduced Ejection Fraction (HFrEF), Coronary Heart Disease (CHD); age from 40 Years; to 80 Years

Sample size100

InterventionYiqi Fumai Lyophilized Injection Plus Guideline-Directed Me…

ComparatorStable guideline-directed medical therapy alone

Setting4 sites: China

Reported figures

Quoted from the source exactly as published.

Planned enrollment100

Primary outcome 1Percentage of participants with KCCQ-CSS improvement ≥5 points at Day 10

Primary outcome 2Percentage of participants with NT-proBNP decrease ≥30% at Day 10

Planned intervention duration10 days

Planned follow-up duration90 days

Clinical bottom line

Caveats

This is a registry record only; no results have been posted or published.
Recruitment status is 'NOT_YET_RECRUITING'; the study has not begun enrollment.
Phase designation is 'NA'; unclear whether this is Phase 2 or 3 and whether there is blinding.
Generalizability may be limited to four hospitals in China; international applicability unknown.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Interventional design with planned follow-up; phase not specified in registry.

Directness

moderate

Clinical outcomes (KCCQ-CSS, NT-proBNP) relevant to heart failure; surrogate biomarker endpoints.

Consistency

insufficient

No results reported; cannot assess consistency with prior evidence.

Risk of bias

insufficient

Study not yet recruiting; randomization, blinding, and conduct details not yet available.

Sample adequacy

limited

Planned enrollment 100 participants; single-country, four-site recruitment limits generalizability.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07803471). This is a study registration, not published results. Lead sponsor: China Academy of Chinese Medical Sciences. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 100 participants (ESTIMATED). Conditions: Chronic Heart Failure, Heart Failure With Reduced Ejection Fraction (HFrEF), Coronary Heart Disease (CHD). Interventions: DRUG: Yiqi Fumai Lyophilized Injection(YQFM); OTHER: Stable Guideline-Directed Medical Therapy. Primary outcome measures: Percentage of Participants With a KCCQ-CSS Response at Day 10 , Baseline (Day 0) to Day 10 before the Day 10 infusion; Percentage of Participants With an NT-proBNP Response at Day 10 , Baseline (Day 0) to Day 10 before the Day 10 infusion. Brief 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Yiqi Fumai Lyophilized Injection(YQFM)NCT07803471China Academy of Chinese Medical SciencesHeart Failure With Reduced Ejection Fraction (hfref)Stable Guideline-Directed Medical TherapyChronic Heart FailureCoronary Heart Disease (CHD)