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

Ischemic Heart Failure Clinical Trial

— CACT-IHF  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01555320
• Other study ID #: 201007001-02
• 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

• Heart Failure
• Ischemia
• Ischemic Heart Failure

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