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

March 19, 2013 updated by: Jingyuan Mao, State Administration of Traditional Chinese Medicine of the People's Republic of China

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

640

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Anhui, China
        • Recruiting
        • The first affiliated hospital of Anhui University of TCM
        • Contact:
        • Principal Investigator:
          • Xiaohua Dai, Dr.
      • Beijing, China
        • Recruiting
        • Dong Fang Hospital
        • Contact:
        • Principal Investigator:
          • Yang Wu, Dr.
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Fuwai Hospital
        • Contact:
        • Principal Investigator:
          • Jian Zhang, Prof
      • Beijing, Beijing, China
        • Recruiting
        • Beijing Hospital of Traditional Chinese Medicine
        • Contact:
        • Principal Investigator:
          • Hongxu Liu, Prof
      • Beijing, Beijing, China
        • Recruiting
        • Xiyuan Hospital of China Academy of Chinese Medical Sciences
        • Contact:
        • Principal Investigator:
          • Yang Miao, Dr.
    • Guangdong
      • Guangdong, Guangdong, China
        • Recruiting
        • Guangdong Provincial Hospital of TCM
        • Contact:
        • Principal Investigator:
          • Huanlin Wu, Prof
    • Guizhou
      • Guiyang, Guizhou, China
        • Recruiting
        • Second Affiliated Hospital of TCM College Guiyang
        • Contact:
        • Principal Investigator:
          • Tao Xu, Dr.
    • Hebei
      • Baoding, Hebei, China
        • Recruiting
        • 252 Hospital of Chinese People's Liberation Army
        • Contact:
        • Principal Investigator:
          • Xuebin Cao, Dr.
    • Heilongjiang
      • Heilongjiang, Heilongjiang, China
        • Recruiting
        • The 1st Affiliated Hospital of Heilongjiang Traditional Chinese Medicine University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yabin Zhou, Prof
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • The first affiliated hospital of henan university of TCM
        • Contact:
        • Principal Investigator:
          • Mingjun Zhu, Dr.
    • Hunan
      • Hengyang, Hunan, China
        • Recruiting
        • The Affiliated Nanhua Hospital of Nanhua University
        • Contact:
          • Huan Liu, Dr.
        • Sub-Investigator:
          • Xiaofeng Ma, Dr.
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Jiangsu Province Traditional Chinese Medicine Hospital
        • Contact:
        • Principal Investigator:
          • Xiaohu Chen, Dr.
      • Nanjing, Jiangsu, China
        • Recruiting
        • Nanjing Hospital of T.C.M
        • Contact:
        • Principal Investigator:
          • Ning Gu, Dr.
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Recruiting
        • The Affiliated Hospital of Jiangxi University of TCM
        • Contact:
        • Principal Investigator:
          • Zhongyong Liu, Dr.
    • Jilin
      • Changchun, Jilin, China
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
        • Principal Investigator:
          • Yaqiu Jiang, Dr.
      • Changchun, Jilin, China
        • Recruiting
        • The Affiliated Hospital To Changchun University of Chinese Medicine
        • Contact:
        • Principal Investigator:
          • Yue Deng, Dr.
    • Liaoning
      • Shenyang, Liaoning, China
        • Recruiting
        • The First Hospital of China Medical University
        • Contact:
        • Principal Investigator:
          • Xiaojuan Bai, Dr.
      • Shenyang, Liaoning, China
        • Recruiting
        • Shengjing Hospital Of China Medical University
        • Contact:
        • Principal Investigator:
          • Suning Chen, Prof
      • Shenyang, Liaoning, China
        • Recruiting
        • Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
        • Contact:
        • Principal Investigator:
          • Fengrong Wang, Dr.
      • Shenyang, Liaoning, China
        • Recruiting
        • The Second Affiliated Hospital of Liaoning University of traditional Chinese Medicine
        • Contact:
        • Principal Investigator:
          • Bo Dong, Dr.
    • Shaanxi
      • Xianyang, Shaanxi, China
        • Recruiting
        • Second Affiliated Hospital of Shaanxi University of Chinese Medicine
        • Contact:
        • Principal Investigator:
          • Yonggang Wang, Dr.
    • Shandong
      • Shandong, Shandong, China
        • Recruiting
        • Shandong Province Traditional Chinese Medicine University Affiliated Hospital
        • Contact:
        • Principal Investigator:
          • Yitao Xue
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School
        • Contact:
        • Principal Investigator:
          • Fengru Zhang, Dr.
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Shuguang Hospital
        • Contact:
        • Principal Investigator:
          • Xiaolong Wang, Dr.
    • Shanxi
      • Taiyuan, Shanxi, China
        • Recruiting
        • Traditional Chinese Medicine Hospital of Shan Xi Province
        • Contact:
        • Principal Investigator:
          • Tianfu Niu, Dr.
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • Teaching Hospital of Chengdu University of TCM
        • Contact:
        • Principal Investigator:
          • Weixing Wang, Dr.
    • Tianjin
      • Tianjin, Tianjin, China
        • Recruiting
        • Affiliated Hospital of Medical College of Chinese People's Armed Police Forces
        • Contact:
        • Principal Investigator:
          • Tiemin Jiang, Dr.
      • Tianjin, Tianjin, China
        • Recruiting
        • First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
        • Contact:
        • Principal Investigator:
          • Jingyuan Mao, Dr.
      • Tianjin, Tianjin, China
        • Recruiting
        • Second affiliated hospital of Tianjin university of tcm
        • Contact:
        • Principal Investigator:
          • Yingqiang Zhao, Dr.
      • Tianjin, Tianjin, China
        • Recruiting
        • The 2nd Hospital of Tianjin Medical University
        • Contact:
        • Principal Investigator:
          • Ruyu Yuan, Dr.
      • Tianjin, Tianjin, China
        • Recruiting
        • Tian Jin Chest Hospital
        • Contact:
        • Principal Investigator:
          • Shutao Chen, Dr.
      • Tianjin, Tianjin, China
        • Recruiting
        • Tianjin Academy of Traditional Chinese Medicine Affliated Hospital
        • Contact:
        • Principal Investigator:
          • Ruihong Fan, Dr.
    • Xinjiang
      • Urumqi, Xinjiang, China
        • Recruiting
        • Traditional Chinese Medical Hospital of Xinjiang Uyghur Autonomous Region
        • Contact:
        • Principal Investigator:
          • Xiaofeng Wang, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
6MWT distance
Time Frame: 0 month
0 month
6MWT
Time Frame: 3rd month
3rd month
6MWT
Time Frame: 6th month
6th month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite endpoint
Time Frame: 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.
1st,3rd,6th,9th,12th month
Brain natriuretic peptide (BNP)
Time Frame: 0,6th month
0,6th month
Echocardiography
Time Frame: 0,6th month
0,6th month
Cardiothoracic Ratio(CR)
Time Frame: 0,6th month
0,6th month
Cardiac function classification, NYHA
Time Frame: 0,1st,3rd,6th,9th,12th month
0,1st,3rd,6th,9th,12th month
Minnesota life quality scale
Time Frame: 0,1st,3rd,6th,9th,12th month
0,1st,3rd,6th,9th,12th month
Scores from the four TCM diagnostic methods
Time Frame: 0,1st,3rd,6th,9th,12th month
0,1st,3rd,6th,9th,12th month
blood and urine routine tests,liver and renal function tests,serum electrolytes,electrocardiogram (ECG)
Time Frame: 0,3rd,6thmonth
0,3rd,6thmonth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

September 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

February 29, 2012

First Submitted That Met QC Criteria

March 13, 2012

First Posted (Estimate)

March 15, 2012

Study Record Updates

Last Update Posted (Estimate)

March 20, 2013

Last Update Submitted That Met QC Criteria

March 19, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201007001-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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