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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01555320
Other study ID # 201007001-02
Secondary ID
Status Recruiting
Phase N/A
First received February 29, 2012
Last updated March 19, 2013
Start date March 2012
Est. completion date December 2013

Study information

Verified date March 2013
Source State Administration of Traditional Chinese Medicine of the People's Republic of China
Contact Yazhu Hou, Dr.
Phone 8622-27432325
Email mreleven@163.com
Is FDA regulated No
Health authority China: State Administration of Traditional Chinese Medicine of the People's Republic of China
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Qishen Yiqi Dripping Pills
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.
Qishen Yiqi dripping pills dummy
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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
State Administration of Traditional Chinese Medicine of the People's Republic of China

Country where clinical trial is conducted

China, 

Outcome

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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