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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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).


Condition Intervention
Ischemic Heart Failure
Drug: Qishen Yiqi Dripping Pills
Drug: Qishen Yiqi dripping pills dummy

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

Resource links provided by NLM:


Further study details as provided by State Administration of Traditional Chinese Medicine of the People's Republic of China:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 640
Study Start Date: March 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Qishen Yiqi dripping pills dummy 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.
Experimental: Qishen Yiqi Dripping Pills 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.

  Eligibility

Ages Eligible for Study:   40 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01555320

Contacts
Contact: Yazhu Hou, Dr. 8622-27432325 mreleven@163.com

  Show 33 Study Locations
Sponsors and Collaborators
State Administration of Traditional Chinese Medicine of the People's Republic of China
Investigators
Principal Investigator: Jingyuan Mao, Dr. First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
  More Information

No publications provided by State Administration of Traditional Chinese Medicine of the People's Republic of China

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jingyuan Mao, Prof., First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01555320     History of Changes
Other Study ID Numbers: 201007001-02
Study First Received: February 29, 2012
Last Updated: March 19, 2013
Health Authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China

Additional relevant MeSH terms:
Heart Failure
Ischemia
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014