Clinical Assessment of Complementary Treatment With Qishen Yiqi Dripping Pills on Ischemic Heart Failure (CACT-IHF)

This study is currently recruiting participants.
Verified March 2013 by State Administration of Traditional Chinese Medicine of the People's Republic of China
Sponsor:
Information provided by (Responsible Party):
Jingyuan Mao, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01555320
First received: February 29, 2012
Last updated: March 19, 2013
Last verified: March 2013

February 29, 2012
March 19, 2013
March 2012
September 2013   (final data collection date for primary outcome measure)
  • 6MWT distance [ Time Frame: 0 month ] [ Designated as safety issue: No ]
  • 6MWT [ Time Frame: 3rd month ] [ Designated as safety issue: No ]
  • 6MWT [ Time Frame: 6th month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01555320 on ClinicalTrials.gov Archive Site
  • Composite endpoint [ Time Frame: 1st,3rd,6th,9th,12th month ] [ Designated as safety issue: No ]
    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) [ Time Frame: 0,6th month ] [ Designated as safety issue: No ]
  • Echocardiography [ Time Frame: 0,6th month ] [ Designated as safety issue: No ]
  • Cardiothoracic Ratio(CR) [ Time Frame: 0,6th month ] [ Designated as safety issue: No ]
  • Cardiac function classification, NYHA [ Time Frame: 0,1st,3rd,6th,9th,12th month ] [ Designated as safety issue: No ]
  • Minnesota life quality scale [ Time Frame: 0,1st,3rd,6th,9th,12th month ] [ Designated as safety issue: No ]
  • Scores from the four TCM diagnostic methods [ Time Frame: 0,1st,3rd,6th,9th,12th month ] [ Designated as safety issue: No ]
  • blood and urine routine tests,liver and renal function tests,serum electrolytes,electrocardiogram (ECG) [ Time Frame: 0,3rd,6thmonth ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Clinical Assessment of Complementary Treatment With Qishen Yiqi Dripping Pills on Ischemic Heart Failure
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).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Ischemic Heart Failure
  • 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.
  • Drug: 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.
  • Placebo Comparator: Qishen Yiqi dripping pills dummy
    Intervention: Drug: Qishen Yiqi dripping pills dummy
  • Experimental: Qishen Yiqi Dripping Pills
    Intervention: Drug: Qishen Yiqi Dripping Pills
Hou YZ, Wang S, Zhao ZQ, Wang XL, Li B, Soh SB, Mao JY. Clinical assessment of complementary treatment with Qishen Yiqi dripping pills on ischemic heart failure: study protocol for a randomized, double-blind, multicenter, placebo-controlled trial (CACT-IHF). Trials. 2013 May 14;14:138. doi: 10.1186/1745-6215-14-138.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
640
December 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
40 Years to 79 Years
No
Contact: Yazhu Hou, Dr. 8622-27432325 mreleven@163.com
China
 
NCT01555320
201007001-02
Yes
Jingyuan Mao, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
State Administration of Traditional Chinese Medicine of the People's Republic of China
Not Provided
Principal Investigator: Jingyuan Mao, Dr. First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
State Administration of Traditional Chinese Medicine of the People's Republic of China
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP