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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
640

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
State Administration of Traditional Chinese Medicine of the People's Republic of China

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2013

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 29, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201007001-02

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