Qishen Yiqi Dripping Pills in Treatment of Chronic Heart FailUre

Official title

Qishen Yiqi Dripping Pills in Treatment of Chronic Heart FailUre With Reduced Ejection FrAction Resorted From Coronary Heart Disease (Syndrome of Qi Deficiency With Blood Stasis): A Phase 3 Randomized ControLled TrIal on Efficacy and SaFetY (QUALIFY)

Overview

This trial will evaluate the efficacy and safety of Qishen Yiqi Dripping Pills in treatment of Chronic Heart Failure with reduced ejection fraction resorted from Coronary Heart Disease (Syndrome of Qi Deficiency with Blood Stasis).

Interventions

• Drug Qishen Yiqi Dripping Pills 2 bags
  Qishen Yiqi Dripping Pills contain Qishen Yiqi Dripping Pills 2 bags(0.52g dripping pills per bag), take orally half an hour after meals, 3 times a day for 12 weeks
• Drug Qishen Yiqi Dripping Pills placebo 2 bags
  Qishen Yiqi Dripping Pills placebo contain Qishen Yiqi Dripping Pills placebo 2 bags(0.52g dripping pills placebo per bag), take orally half an hour after meals, 3 times a day for 12 weeks

Primary outcome measures

• Change From Baseline in 6-minute Walk Distance (6MWD) at Week 12 (Larger Distances Represent Better Exercise Functional Capacity). [Time frame: At baseline and at week 12.]

Secondary outcome measures (12)

• Change From Baseline in 6-minute Walk Distance (6MWD) at Week 4 and Week 8. [Time frame: At baseline and at week 4 and week 8.]
• Change From Baseline in Minnesota Living with Heart Failure Questionnaire (MLHFQ) Score at Week 4, Week 8 and Week 12. (Higher Scores Represent Lower Quality of Life). [Time frame: At baseline and at week 4, week 8 and week 12.]
• The Disappearance Rate of Heart Failure Symptoms (shortness of breath, fatigue, edema) at Week 4, Week 8 and Week 12. [Time frame: At baseline and at week 4, week 8 and week 12.]
• Change From Baseline in Traditional Chinese Medicine (TCM) Syndrome Score at Week 4, Week 8 and Week 12. (Higher Scores Represent Sever TCM Syndrome). [Time frame: At baseline and at week 4, week 8 and week 12.]
• The Total Effective Rate in Traditional Chinese Medicine (TCM) Syndrome at Week 4, Week 8 and Week 12. [Time frame: At baseline and at week 4, week 8 and week 12.]
• The Number of Participants at Each Level of NYHA Functional Classification and the Proportion of Participants who Improved/Unchanged/Worsened at Week 4, Week 8 and Week 12 Compared With Baseline. [Time frame: At baseline and at week 4, week 8 and week 12.]
• Change From Baseline in Echocardiographic Measures LVEDD (Left Ventricular End Diastolic Diameter) at Week 12. [Time frame: At baseline and at week 12.]
• Change From Baseline in Echocardiographic Measures LVEDV (Left Ventricular End Diastolic Volume) at Week 12. [Time frame: At baseline and at week 12.]
• Change From Baseline in Echocardiographic Measures LVESV (Left Ventricular End Systolic Volume) at Week 12. [Time frame: At baseline and at week 12.]
• Change From Baseline in Echocardiographic Measures LVEF (Left Ventricular Ejection Fraction) at Week 12. [Time frame: At baseline and at week 12.]
• Change From Baseline in Echocardiographic Measures SV (Stroke Volume) at Week 12. [Time frame: At baseline and at week 12.]
• Change From Baseline in Echocardiographic Measures CO (Cardiac Output) at Week 12. [Time frame: At baseline and at week 12.]

Eligibility criteria

Inclusion criteria

• Male or female subjects aged ≥ 18 years and ≤80 years when signing the informed consent form.
• Conformed to the diagnostic criteria of coronary heart disease and chronic heart failure.
• Conformed to the TCM syndrome differentiation standard of chronic heart failure syndrome of Qi deficiency and blood stasis.
• NYHA Functional Classification Ⅱ-Ⅲ.
• Left ventricular ejection fraction (LVEF) < 45% (modified two-plane Simpson method).
• Received standardized drug therapy for chronic heart failure at least 2 weeks before randomization without adjustment of dose, and did not receive intravenous therapy (vasoactive drugs, diuretics) within 2 weeks.
• Voluntarily participate in the clinical trial, sign the informed consent form, and be able to understand and comply with the trial procedures.

Exclusion criteria

• Heart failure caused by other cardiovascular diseases, such as infectious endocarditis, cardiac amyloidosis, genetic abnormalities (genetic factors related to hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy), valve and cardiac structure abnormalities (moderate or above aortic valve stenosis, other severely narrowed or incompetent heart valves, congenital heart disease), constrictive pericarditis, moderate or large pericardial effusion.
• Heart failure caused by other non-cardiovascular diseases, such as severe infection, autoimmune diseases, tumor metastasis or infiltration, pulmonary heart disease, primary pulmonary hypertension, secondary severe pulmonary hypertension, kidney diseases, liver diseases, cardiac toxic injury (cardiotoxic drugs such as anti-tumor drugs, alcoholic cardiomyopathy).
• Within 3 months before receiving the investigational drug, had acute myocardial infarction, undergone revascularization \[percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG)\] treatment, undergone left ventricular assist device \[cardiac resynchronization therapy (CRT), implantable cardioverter defibrillator (ICD), etc.\] treatment, undergone cardiac surgery (left ventricular reconstruction, heart transplantation, etc.) treatment, had acute cerebrovascular events (acute ischemic stroke, cerebral hemorrhage, transient ischemic attack).
• Planned to undergo revascularization (PCI, CABG, etc.) or left ventricular assist device (CRT, ICD, etc.) treatment, or other cardiac surgery during the trial.
• Had severe, progressive, or uncontrolled diseases, including but not limited to immune system, endocrine system, blood system, urinary system, liver and gallbladder system, respiratory system, nervous system, mental system, cardiovascular system, gastrointestinal system or infectious diseases, malignant tumors, etc.
• Had uncontrolled hypertension (after antihypertensive treatment, systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg), or had hypotension (systolic blood pressure < 80 mmHg and/or diastolic blood pressure < 50 mmHg).
• Severe arrhythmias such as ventricular tachycardia, second-degree type II or above sinus or atrioventricular conduction block without pacemaker treatment.
• Abnormal liver function tests \[alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times the upper limit of the normal value of the laboratory in this center\], or abnormal renal function tests \[serum creatinine (Cr) > 1.5 times the upper limit of the normal value of the laboratory\].
• Glycated hemoglobin (HbA1c) ≥ 9.0%.
• Hemoglobin (Hb) < 90 g/L.
• Serum potassium concentration > 5.5 mmol/L.
• Need to take anticoagulants, dose stable for less than 1 month, or INR > 3.0.
• Need to take antiplatelet drugs, dose stable for less than 1 month, and platelets lower than the lower limit of the normal value.
• Allergic to the Chinese medicine formula of Qishen YiQi (QSYQ) Dripping Pills (Astragalus membranaceus, Salvia miltiorrhiza, Panax notoginseng, and Dalbergia odorifera), or allergic to other Chinese medicines with the same ingredients or the same therapeutic functions.
• Within 2 weeks before randomization, had received drugs affecting exercise tolerance assessment (such as trimetazidine, renozine, coenzyme Q10, levocarnitine, and androgens) or Chinese medicine preparations with the same ingredients or the same therapeutic functions.
• Had absolute contraindications for the 6-minute walk test or was unable to complete the 6-minute walk test.
• Had participated in other interventional drug clinical trials within 1 month before screening.
• Pregnant or lactating women, or had a pregnancy plan or could not take effective contraceptive measures from the screening period to the end of the trial and within 1 month after the last administration.
• Any other circumstances where other researchers deem it inappropriate for a participant to take part in the trial, such as if the participant has potential issues with compliance, is unable to complete all the examinations and evaluations as per the protocol requirements, or if there are uncontrollable risks associated with participating in the trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 60 centers

• Bozhou People's Hospital — Bozhou
• The First Affiliated Hospital of University of Science and Technology of China (Anhui Prov — Hefei
• Anhui Suzhou Municipal Hospital — Suzhou
• Xiyuan Hospital, China Academy of Chinese Medical Sciences — Beijing
• Fujian Provincial Hospital — Fuzhou
• Gansu Provincial Hospital — Lanzhou
• The Second Hospital of Lanzhou University — Lanzhou
• Qingyang People's Hospital — Qingyang
• … and 52 more centers

Identifiers

NCT: NCT07687186 · TSL-TCM-QSYQDW-HFrEF-Ⅲ

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗