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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
640
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.
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.
Beijing Hospital of Traditional Chinese Medicine
Beijing, Beijing Municipality, China
RECRUITINGFuwai Hospital
Beijing, Beijing Municipality, China
RECRUITINGXiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGGuangdong Provincial Hospital of TCM
Guangdong, Guangdong, China
6MWT distance
Time frame: 0 month
6MWT
Time frame: 3rd month
6MWT
Time frame: 6th month
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.
Time frame: 1st,3rd,6th,9th,12th month
Brain natriuretic peptide (BNP)
Time frame: 0,6th month
Echocardiography
Time frame: 0,6th month
Cardiothoracic Ratio(CR)
Time frame: 0,6th month
Cardiac function classification, NYHA
Time frame: 0,1st,3rd,6th,9th,12th month
Minnesota life quality scale
Time frame: 0,1st,3rd,6th,9th,12th month
Scores from the four TCM diagnostic methods
Time frame: 0,1st,3rd,6th,9th,12th month
blood and urine routine tests,liver and renal function tests,serum electrolytes,electrocardiogram (ECG)
Time frame: 0,3rd,6thmonth
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Second Affiliated Hospital of TCM College Guiyang
Guiyang, Guizhou, China
RECRUITING252 Hospital of Chinese People's Liberation Army
Baoding, Hebei, China
RECRUITINGThe 1st Affiliated Hospital of Heilongjiang Traditional Chinese Medicine University
Heilongjiang, Heilongjiang, China
RECRUITINGThe First Affiliated Hospital of Henan University of TCM
Zhengzhou, Henan, China
RECRUITINGThe Affiliated Nanhua Hospital of Nanhua University
Hengyang, Hunan, China
RECRUITINGJiangsu Province Traditional Chinese Medicine Hospital
Nanjing, Jiangsu, China
RECRUITING...and 23 more locations