An interventional study of Yiqi Fumai Lyophilized Injection(YQFM) and Stable Guideline-Directed Medical Therapy in Chronic Heart Failure, Heart Failure With Reduced Ejection Fraction (HFrEF) and Coronary Heart Disease (CHD), sponsored by China Academy of Chinese Medical Sciences. Not yet recruiting at 4 sites in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by China Academy of Chinese Medical Sciences · Not applicable, Interventional, and Treatment
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.
This record covers the prospective interventional component of a broader integrated research program. The registered component is a multicenter, prospective, open-label, single-arm performance-goal study in 100 hospitalized adults aged 40 to 80 years with stable chronic heart failure with reduced ejection fraction caused by coronary heart disease, NYHA class II or III symptoms, left ventricular ejection fraction of 40% or less, NT-proBNP of at least 450 pg/mL, and Qi and Yin deficiency syndrome. All participants will receive Yiqi Fumai lyophilized injection in addition to stable guideline-directed medical therapy. The study drug will be administered as 8 vials once daily, diluted in 250 mL of 0.9% sodium chloride, by intravenous infusion at 35 to 40 drops per minute for a planned 10 days. Clinically necessary discharge, transfer, treatment modification, or rescue therapy will not be delayed to complete study procedures. The co-primary outcomes are Day 11 KCCQ-CSS response and Day 11 NT-proBNP response, both measured at the end-of-treatment visit, targeted 24 +/- 4 hours after initiation of the 10th infusion; no study drug is infused on Day 11. KCCQ-CSS response is generally defined as an increase of at least 5 points from baseline. NT-proBNP response is defined as a decrease of at least 30% from baseline using paired central-laboratory results. Death, heart-failure rehospitalization, major rescue therapy, or inability to complete assessment because of worsening heart failure before Day 11 is counted as nonresponse. The KCCQ-CSS performance goal is p0=50% with p1=65%, and the NT-proBNP performance goal is p0=45% with p1=60%. Testing follows a prespecified fixed order and intersection-union principle; both outcomes must pass for overall co-primary success. Follow-up assessments occur at Day 30 and Day 90. A prespecified subgroup of 50 participants, randomly selected within center and NYHA strata, will undergo paired Day 1 pre-infusion and Day 11 end-of-treatment multi-omics sampling. The broader protocol also includes a separate retrospective comparative cohort of 200 patients for external triangulation and economic modeling; those retrospective patients are not part of the enrollment or design entered in this interventional record.
1,520 studies on the registry are indexed under Coronary Disease; 167 are open to participants now.
This study's planned enrollment of 100 is below the median of 160 across 778 interventional studies indexed under Coronary Disease.
Browse Coronary Disease studies →China Academy of Chinese Medical Sciences is the lead sponsor of 62 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive Yiqi Fumai lyophilized injection in addition to stable guideline-directed medical therapy. The planned treatment course is 10 once-daily intravenous infusions. Clinically necessary early discharge, rescue treatment, transfer, or discontinuation takes priority over protocol completion and will be documented.
Drug: Yiqi Fumai Lyophilized Injection(YQFM) · Other: Stable Guideline-Directed Medical Therapy
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.
Also known as: Yiqi Fumai Injection
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.
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.
Time frame: Baseline (Day 1 before the first infusion) to Day 11, 24 +/- 4 hours after initiation of the 10th infusion (no Day 11 infusion)
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.
Time frame: Baseline (Day 1 before the first infusion) to Day 11, 24 +/- 4 hours after initiation of the 10th infusion (no Day 11 infusion)
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.
Time frame: Baseline (Day 1 before the first infusion); Day 11 (end of treatment; no infusion); Day 30 +/- 3 days; Day 90 +/- 7 days
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.
Time frame: Baseline (Day 1 before the first infusion); Day 11 (end of treatment; no infusion); Day 30 +/- 3 days; Day 90 +/- 7 days
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.
Time frame: Baseline (Day 1) to Day 11, Day 30 +/- 3 days, and Day 90 +/- 7 days
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.
Time frame: Baseline to Day 90 +/- 7 days
Change From Baseline in Left Ventricular End-Diastolic Diameter
Left ventricular end-diastolic diameter is obtained by standardized transthoracic echocardiography with central review of DICOM images.
Time frame: Baseline to Day 90 +/- 7 days
Percentage of Participants With Improvement in NYHA Functional Class
Improvement is defined as a decrease of at least one NYHA functional class from baseline without heart-failure rehospitalization or death before the assessment.
Time frame: Baseline (Day 1) to Day 11, Day 30 +/- 3 days, and Day 90 +/- 7 days
Change From Baseline in Minnesota Living With Heart Failure Questionnaire Total Score
The total score change is summarized, together with the proportions achieving a decrease of at least 5 points or at least 20%. Day 10 is descriptive; Days 30 and 90 are supportive.
Time frame: Baseline (Day 1); Day 11; Day 30 +/- 3 days; Day 90 +/- 7 days
Change From Baseline in 6-Minute Walk Distance
Change in 6-minute walk distance is summarized as a continuous measure and as the proportion with an increase of at least 15 meters. Day 90 is the key supportive time point. Tests are performed under standardized conditions when clinically safe; an unperformed test is not assigned a value of zero.
Time frame: Baseline (Day 1); Day 11; Day 30 +/- 3 days; Day 90 +/- 7 days
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.
Time frame: Baseline (Day 1); Day 11; Day 30 +/- 3 days; Day 90 +/- 7 days
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.
Time frame: Baseline through Day 90 +/- 7 days
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.
Time frame: Through Day 30 and Day 90
Incidence of Major Adverse Cardiovascular Events
Major adverse cardiovascular events are recorded according to the prespecified clinical-event definitions in the statistical analysis plan.
Time frame: Through Day 90 +/- 7 days
Incidence of Cardiovascular Death
The proportion of participants who die from a cardiovascular cause during follow-up.
Time frame: Through Day 90 +/- 7 days
Incidence of All-Cause Death
The proportion of participants who die from any cause during follow-up.
Time frame: Through Day 90 +/- 7 days
Incidence of Adverse Events and Serious Adverse Events
All adverse events and serious adverse events are recorded regardless of causal relationship, including onset and end dates, severity, seriousness, action taken, outcome, study-drug discontinuation, additional hospitalization, additional costs, and investigator-assessed causality. Infusion reactions and hypersensitivity reactions are events of special interest.
Time frame: From the first study-drug infusion through Day 90 +/- 7 days
Change From Baseline in Safety Laboratory Measures
Prespecified laboratory safety measures include ALT, AST, total and direct bilirubin, ALP, GGT, albumin, serum creatinine, BUN, eGFR, potassium, sodium, chloride, calcium, and urinalysis measures. Each analyte is summarized separately in its original unit and by clinically significant abnormality.
Time frame: Baseline (Day 1) to Day 11
Participant-Level Healthcare Resource Use and Costs
Resource use includes index hospitalization days, intensive-care use and days, heart-failure medications, tests, procedures, materials, adverse-event management, and heart-failure rehospitalization. Direct medical costs are calculated as resource quantity multiplied by standardized unit price and reported in Chinese yuan for a prespecified price year. Research-only central testing and omics costs are identified separately from routine clinical costs.
Time frame: Baseline through Day 90 +/- 7 days
Participant-Level Direct Nonmedical and Indirect Costs
Direct nonmedical costs include transportation, meals, lodging, and caregiving. Indirect costs include productivity losses of participants and caregivers and are estimated using the human-capital approach under prespecified rules.
Time frame: Baseline through Day 90 +/- 7 days
Model-Based Incremental Cost-Effectiveness and Cost-Utility Ratios
Decision-tree and Markov models integrate prospective participant-level parameters, comparative effects and direct medical costs from the separate retrospective cohort, and prespecified external evidence. Outputs include incremental cost per additional KCCQ-CSS responder, incremental cost per additional NT-proBNP responder, and incremental cost per quality-adjusted life-year. Enter this outcome only if the sponsor intends to report the integrated model under this NCT record.
Time frame: Index hospitalization to 90 days; model horizons of 1 year, 5 years, and lifetime
Paired Changes in Blood Transcriptomic, Proteomic, and Metabolomic Profiles
Exploratory paired analyses assess differential gene expression, plasma protein abundance, and plasma metabolite and lipid profiles. Analyses include quality control, batch correction, false-discovery-rate control, pathway enrichment, and integration with clinical response measures. Findings are hypothesis-generating only.
Time frame: Baseline (Day 1 before the first infusion) to Day 11 end-of-treatment sampling, targeted 24 +/- 4 hours after initiation of the 10th infusion, in a 50-participant subgroup
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Jul 2027, 10 months later.
Of 178 non-industry interventional studies with no phase under Coronary Disease, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 51. This study's planned 10 months is below that.
Counting every sponsor, half of 200 studies reached it within 25 months; a quarter within 14 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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China Academy of Chinese Medical Sciences