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

Not Applicable

• Conditions: Ischemic Heart Failure
• Interventions: Drug: Qishen Yiqi dripping pills dummy; Drug: Qishen Yiqi Dripping Pills

• Registration Number: NCT01555320
• Lead Sponsor: State Administration of Traditional Chinese Medicine of the People's Republic of China

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-29
• Study Start: 2012-03
• Study First Submitted QC: 2012-03-13
• Study First Posted: 2012-03-15
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-19
• Last Update Posted: 2013-03-20
• Primary Completion: 2013-09
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 640

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Qishen Yiqi dripping pills dummy	Qishen Yiqi dripping pills dummy	-
Qishen Yiqi Dripping Pills	Qishen Yiqi Dripping Pills	-

Primary Outcome Measures

Name	Time	Method
6MWT distance	0 month
6MWT	6th month

Secondary Outcome Measures

Name	Time	Method
Composite endpoint	1st,3rd,6th,9th,12th month	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.
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

Trial Locations

Locations (33)

Beijing Hospital of Traditional Chinese Medicine; 🇨🇳 Beijing, Beijing, China

Fuwai Hospital; 🇨🇳 Beijing, Beijing, China

Xiyuan Hospital of China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, Beijing, China

Guangdong Provincial Hospital of TCM; 🇨🇳 Guangdong, Guangdong, China

Second Affiliated Hospital of TCM College Guiyang; 🇨🇳 Guiyang, Guizhou, China

252 Hospital of Chinese People's Liberation Army; 🇨🇳 Baoding, Hebei, China

The 1st Affiliated Hospital of Heilongjiang Traditional Chinese Medicine University; 🇨🇳 Heilongjiang, Heilongjiang, China

The First Affiliated Hospital of Henan University of TCM; 🇨🇳 Zhengzhou, Henan, China

The Affiliated Nanhua Hospital of Nanhua University; 🇨🇳 Hengyang, Hunan, China

Jiangsu Province Traditional Chinese Medicine Hospital; 🇨🇳 Nanjing, Jiangsu, China

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