Clinical Assessment of Complementary Treatment With Qishen Yiqi Dripping Pills on Ischemic Heart Failure

Study Overview
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Brief Summary
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CACT-IHF aims to evaluate the clinical efficacy and safety of Qishen Yiqi Dripping Pills in treating ischemic heart failure. Meeting the diagnosis, inclusion and exclusion criteria, the study plans to recruit 640 cases from 35 upper class hospitals in China, who are divided into two groups (treatment and control group) by central randomization service. The treatment group will be administrated with one bag of Qishen Yiqi Dripping Pills (0.52g/bag) three times a day in addition to standardized western medications. Whereas the control group will be given one bag of Qishen Yiqi Dripping Pills dummy (0.52g/bag) three times a day in addition to standardized western medications. Efficacy indicators include primary indicator (6 minute walk test) and secondary indicators: composite endpoint consisting of all-cause death, emergency/re-admission to hospital due to HF, frequency of re-admission due to cardiovascular disease, acute coronary syndrome, severe arrhythmia, cardiac shock, revascularization, stroke, pulmonary embolism and peripheral vascular incidences, etc.; Brain Natriuretic Peptide; echocardiography; cardiothoracic ratio; NYHA cardiac function classification; Minnesota life quality scale; scores from the four traditional chinese medicine (TCM) diagnostic methods). Other indicators include blood cholesterol, triglyceride, high density cholesterol and low density cholesterol. Safety indicators include blood pressure, heart rate, blood and urine routine tests, liver and renal function tests, serum electrolytes, electrocardiogram and adverse events. All of the patients will receive interventional drug treatment for 6 months. Follow up is needed on the 1st, 3rd, 6th, 9th, 12th month after recruitment. All patients will be followed up until the end of study (Refers to the 12th month of the last case recruited into the study).

Official Title
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Clinical Assessment of Complementary Treatment With Qishen Yiqi Dripping Pills on Ischemic Heart Failure (CACT-IHF) A Randomized, Double-blind, Multicenter, Placebo-controlled Trial

Conditions
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Ischemic Heart Failure

Intervention / Treatment
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* Drug: Qishen Yiqi Dripping Pills
* Drug: Qishen Yiqi dripping pills dummy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 40 to 79 Patients with ischemic heart failure： LVEF less than or equal to 45% measured by echocardiography in modified Simpson method History of prior myocardial infarction with or without percutaneous coronary intervention (PCI) or/and coronary artery bypass grafting (CABG); Coronary angiography (CAG) or coronary CTA shows more than or equal to 50% stenosis in at least one of the main coronary arteries with or without revascularization, of which the researcher thinks that it is closely related to heart failure; With or without dyspnea, fatigue and fluid retention (edema) etc. History of heart failure or present with heart failure symptoms for at least 3 months; New York Heart Association (NYHA) Class II to IV; Submitted informed consent Exclusion Criteria: Acute heart failure or acute exacerbation of chronic heart failure Those who have one of the following diseases: Acute coronary syndrome within 30 days Revascularization therapy within 6 months Uncontrolled hypertension with systolic pressure more than or equal to 180mmHg and/or diastolic pressure more than or equal to 110mmHg Second degree type 2 or worse sinoatrial/atrioventricular block without implantation of pacemaker or uncontrolled malignant cardiac arrhythmia Dilated cardiomyopathy Hypertrophic obstructive cardiomyopathy Myocarditis Pulmonary artery embolism Severe valvular heart disease Pulmonary heart disease Stroke within 6 months Cardiac resynchronization therapy Applied diuretics, cardiotonic agents or vasodilators intravenously within 7 days Severe endocrine diseases such as hyperthyroidism, etc. History of malignant tumor Hemoglobin (HB )≤ 9g/dl Alanine aminotransferase (ALT) > 2 times the upper limit of normal Serum creatinine > 265 μmol/L Mental disorder Being pregnant, planning for pregnancy or breastfeeding Suspicious or definite allergy to intervention drugs Participated in other trials within 2 months Unable to walk autonomously due to physical disabilities

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Qishen Yiqi dripping pills dummy<br> | Drug: Qishen Yiqi dripping pills dummy<br>* One packet of Qishen Yiqi Dripping Pills dummy (0.52g) will be given three times a day in addition to regular western medications for the first 6 months, and regular western medications only for the subsequent 6 months.<br>|
| Experimental: Qishen Yiqi Dripping Pills<br> | Drug: Qishen Yiqi Dripping Pills<br>* One packet of Qishen Yiqi Dripping Pills (0.52g) will be given three times a day in addition to regular western medications for the first 6 months, and regular western medications only for the subsequent 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6MWT distance |  | 0 month | 
| 6MWT |  | 3rd month | 
| 6MWT |  | 6th month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint | all-cause death, frequency of emergency/re-admission to hospital due to HF, frequency of re-admission due to cardiovascular disease, acute coronary syndrome, severe arrhythmia, cardiac shock, revascularization, stroke, pulmonary embolism and peripheral vascular incidences, etc. | 1st,3rd,6th,9th,12th month | 
| Brain natriuretic peptide (BNP) |  | 0,6th month | 
| Echocardiography |  | 0,6th month | 
| Cardiothoracic Ratio(CR) |  | 0,6th month | 
| Cardiac function classification, NYHA |  | 0,1st,3rd,6th,9th,12th month | 
| Minnesota life quality scale |  | 0,1st,3rd,6th,9th,12th month | 
| Scores from the four TCM diagnostic methods |  | 0,1st,3rd,6th,9th,12th month | 
| blood and urine routine tests,liver and renal function tests,serum electrolytes,electrocardiogram (ECG) |  | 0,3rd,6thmonth |