Ischemic Heart Failure Clinical Trial
— CACT-IHFOfficial title:
Clinical Assessment of Complementary Treatment With Qishen Yiqi Dripping Pills on Ischemic Heart Failure (CACT-IHF) A Randomized, Double-blind, Multicenter, Placebo-controlled Trial
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).
Status | Recruiting |
Enrollment | 640 |
Est. completion date | December 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 79 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Anhui University of TCM | Anhui | |
China | 252 Hospital of Chinese People's Liberation Army | Baoding | Hebei |
China | Beijing Hospital of Traditional Chinese Medicine | Beijing | Beijing |
China | Dong Fang Hospital | Beijing | |
China | Fuwai Hospital | Beijing | Beijing |
China | Xiyuan Hospital of China Academy of Chinese Medical Sciences | Beijing | Beijing |
China | The Affiliated Hospital To Changchun University of Chinese Medicine | Changchun | Jilin |
China | The First Hospital of Jilin University | Changchun | Jilin |
China | Teaching Hospital of Chengdu University of TCM | Chengdu | Sichuan |
China | Guangdong Provincial Hospital of TCM | Guangdong | Guangdong |
China | Second Affiliated Hospital of TCM College Guiyang | Guiyang | Guizhou |
China | The 1st Affiliated Hospital of Heilongjiang Traditional Chinese Medicine University | Heilongjiang | Heilongjiang |
China | The Affiliated Nanhua Hospital of Nanhua University | Hengyang | Hunan |
China | The Affiliated Hospital of Jiangxi University of TCM | Nanchang | Jiangxi |
China | Jiangsu Province Traditional Chinese Medicine Hospital | Nanjing | Jiangsu |
China | Nanjing Hospital of T.C.M | Nanjing | Jiangsu |
China | Shandong Province Traditional Chinese Medicine University Affiliated Hospital | Shandong | Shandong |
China | Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School | Shanghai | Shanghai |
China | Shanghai Shuguang Hospital | Shanghai | Shanghai |
China | Affiliated Hospital of Liaoning University of Traditional Chinese Medicine | Shenyang | Liaoning |
China | Shengjing Hospital of China Medical University | Shenyang | Liaoning |
China | The First Hospital of China Medical University | Shenyang | Liaoning |
China | The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine | Shenyang | Liaoning |
China | Traditional Chinese Medicine Hospital of Shan Xi Province | Taiyuan | Shanxi |
China | Affiliated Hospital of Medical College of Chinese People's Armed Police Forces | Tianjin | Tianjin |
China | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine | Tianjin | Tianjin |
China | Second Affiliated Hospital of Tianjin University of TCM | Tianjin | Tianjin |
China | The 2nd Hospital of Tianjin Medical University | Tianjin | Tianjin |
China | Tian Jin Chest Hospital | Tianjin | Tianjin |
China | Tianjin Academy of Traditional Chinese Medicine Affliated Hospital | Tianjin | Tianjin |
China | Traditional Chinese Medical Hospital of Xinjiang Uyghur Autonomous Region | Urumqi | Xinjiang |
China | Second Affiliated Hospital of Shaanxi University of Chinese Medicine | Xianyang | Shaanxi |
China | The First Affiliated Hospital of Henan University of TCM | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
State Administration of Traditional Chinese Medicine of the People's Republic of China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 6MWT distance | 0 month | No | |
Primary | 6MWT | 3rd month | No | |
Primary | 6MWT | 6th month | No | |
Secondary | 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 | No |
Secondary | Brain natriuretic peptide (BNP) | 0,6th month | No | |
Secondary | Echocardiography | 0,6th month | No | |
Secondary | Cardiothoracic Ratio(CR) | 0,6th month | No | |
Secondary | Cardiac function classification, NYHA | 0,1st,3rd,6th,9th,12th month | No | |
Secondary | Minnesota life quality scale | 0,1st,3rd,6th,9th,12th month | No | |
Secondary | Scores from the four TCM diagnostic methods | 0,1st,3rd,6th,9th,12th month | No | |
Secondary | blood and urine routine tests,liver and renal function tests,serum electrolytes,electrocardiogram (ECG) | 0,3rd,6thmonth | Yes |
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