Trials Sponsors Conditions Drugs Pricing

Conditions

Chronic Heart Failure Coronary Heart Disease (CHD)Heart Failure With Reduced Ejection Fraction (HFrEF)

Keywords

Yiqi Fumai lyophilized injectionchronic left ventricular dysfunctionNYHA class II; NYHA class IIIQi and Yin deficiency syndrometraditional Chinese medicine injectionpharmacoeconomic evaluationmulti-omics

Outcome Measures

Primary Outcomes (2)

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.
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.

Study Arms (1)

Yiqi Fumai Lyophilized Injection Plus Guideline-Directed Medical Therapy

EXPERIMENTAL

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

Interventions

Yiqi Fumai Lyophilized Injection(YQFM)Drug

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

Yiqi Fumai Lyophilized Injection Plus Guideline-Directed Medical Therapy

Stable Guideline-Directed Medical Therapy

Eligibility Criteria

Age40 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

China Academy of Chinese Medical Sciences
Otherlead

Study Sites (4)

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, 510120, China

Weihui Lv, PhdCONTACT86-13826273202 weihui.lu@gzucm.edu.cn

The First Affiliated Hospital of Henan University of Chinese Medicine

Zhengzhou, Henan, 450000, China

Xincan Liu, PhdCONTACT86-18637100533 liuxincan103@163.com

Guang'anmen Hospital Jinan Hospital, China Academy of Chinese Medical Sciences

Jinan, Shandong, 250012, China

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

Lianxin Wang
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
PRINCIPAL INVESTIGATOR

Central Study Contacts

Lianxin Wang, PhD

CONTACT

86-13521781839 wlxing2022@163.com

Bai Du, PhD

CONTACT

86-13439689904

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

August 31, 2026

First Posted

September 3, 2026

Study Start

September 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

You may not qualify if:

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.
NYHA class IV, clinical instability, or inability to safely complete the short-term study procedures.
Heart failure caused primarily by severe valvular heart disease, primary cardiomyopathy, congenital heart disease, pericardial disease, cor pulmonale, severe pulmonary hypertension, thyroid dysfunction, severe anemia, infective endocarditis, or another noncoronary cause.
Severe hepatic, renal, or hematologic disease, including ALT or AST greater than 3 times the upper limit of normal, eGFR less than 30 mL/min/1.73 m2, dialysis, severe anemia, or another condition judged unsuitable by the investigator.
Markedly uncontrolled blood pressure or hypotension risk: systolic blood pressure of at least 180 mmHg, diastolic blood pressure of at least 110 mmHg, systolic blood pressure below 90 mmHg, or persistently repeated diastolic blood pressure below 50 mmHg accompanied by dizziness, syncope, oliguria, cold extremities, hypoperfusion, or symptomatic hypotension.
Severe intracerebral hemorrhage, severe sequelae of cerebral infarction, severe cognitive impairment, psychiatric disorder, aphasia, or another condition that interferes with questionnaire assessment or follow-up data collection.
Active malignancy, severe infection, active autoimmune disease, or expected survival of less than 6 months.
Pregnancy or breastfeeding.
Known allergy to Yiqi Fumai lyophilized injection, red ginseng, Ophiopogon japonicus, Schisandra chinensis, or any excipient; or a prior serious adverse reaction to a similar product.
Participation in another clinical study that, in the investigator's judgment, may affect efficacy, safety, adherence, or economic evaluation in this study.
Current use, with planned continuation during the study, or inability to discontinue, of a Qi-tonifying and Yin-nourishing Chinese herbal decoction or proprietary Chinese medicine with effects overlapping those of the study drug.
Any other condition that the investigator considers unsuitable for participation.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

Yiqi Fumai Lyophilized Injection Plus Guideline-Directed Medical Therapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Secondary Outcomes (8)

Other Outcomes (12)

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

Yiqi Fumai Lyophilized Injection Plus Guideline-Directed Medical Therapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Secondary Outcomes (8)

Other Outcomes (12)

You may not qualify if:

Data Sharing

Source record

Locations