Study of Qiliqiangxin Capsule to Treat Dilated Cardiomyopathy (QLQX-DCM)

August 26, 2017 updated by: Yu-Hua Liao, Huazhong University of Science and Technology

A Multi-center, Randomized, Double, Placebo-controlled, Parallel Group Study of Improving Heart Function and Immunoregulation Effects of Qiliqiangxin Capsule in Patients With Dilated Cardiomyopathy

The pathogenesis of dilated cardiomyopathy (DCM) leading to heart failure is closely associated with autoimmunity dysfunction. A few studies represented that Qiliqiangxin capsule, a Chinese medicine, could enhance heart function in chronic heart failure and regulate the balance of TNF-a and IL-10 in myocardial infarction. In this study, to explore the effects of Qiliqiangxin capsule on the improving heart function and immunoregulation in patients with DCM, patients were recruited, anti-heart autoantibodies and some representative cytokines were assayed by enzyme-linked immuno sorbent assay (ELISA), and the efficacy of heart function improvement was compared between Qiliqiangxin capsule and placebo under the standard treatment of DCM.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

374

Phase

  • Phase 4

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
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

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

14 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Dilated Cardiomyopathy (LVEF ≤ 45%)

Exclusion Criteria:

  • Secondary dilated cardiomyopathy (such as ischemic cardiomyopathy, valvular cardiomyopathy, hyperthyroid cardiomyopathy, diabetic cardiomyopathy, anemia cardiomyopathy, and etc.)
  • Coronary heart disease
  • Rheumatic heart disease
  • Pulmonary heart disease
  • Continuous dysarteriotony: hypertension(systolic blood pressure [SBP] ≥ 60mmHg/diastolic blood pressure [DBP] ≥ 100mmHg); hypotension(SBP < 90mmHg/DBP < 60mmHg)
  • Resting heart rate ≤ 50bpm
  • Atrioventricular block patients without permanent pacemaker

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: Placebo
Drug: Placebo
Placebo, similar in color and taste to Qiliqiangxin capsule, is administrated based on the standard heart failure treatment in China. Dosage: 1.2g/times. Frequency: 3 times/day. Duration: The whole study period.
Experimental: Qiliqiangxin capsule
Drug: Qiliqiangxin capsule
Qiliqiangxin capsule is administrated based on the standard heart failure treatment in China. Dosage: 1.2g/times. Frequency: 3 times/day. Duration: The whole study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The value of left ventricular end-diastolic dimension (LVEDd) and left ventricular ejection fraction(LVEF) confirmed by ultrasonic cardiogram (UCG)
Time Frame: 12 months after intervention
12 months after intervention
The levels of serum representative cytokines detected by ELISA
Time Frame: 12 months after intervention
12 months after intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Heart failure aggravation
Time Frame: 12 months after intervention
12 months after intervention
All cause mortality
Time Frame: 12 months after intervention
12 months after intervention
Sudden cardiac death
Time Frame: 12 months after intervention
12 months after intervention
Stroke
Time Frame: 12 months after intervention
12 months after intervention
The dynamic changes of serum representative cytokines detected by ELISA in the treatment group
Time Frame: 12 months after intervention
12 months after intervention

Collaborators and Investigators

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

Sponsor

Huazhong University of Science and Technology

Collaborators

The First Affiliated Hospital with Nanjing Medical University
Wuhan University
Fudan University
RenJi Hospital
China National Center for Cardiovascular Diseases
Tongji Hospital
Ministry of Science and Technology of the People´s Republic of China
First Affiliated Hospital Xi'an Jiaotong University
Shandong Provincial Hospital
The First Affiliated Hospital of Zhengzhou University
Henan Provincial People's Hospital
Wuhan Union Hospital, China
Second Affiliated Hospital of Xi'an Jiaotong University
The Second Affiliated Hospital of Harbin Medical University
First Affiliated Hospital of Harbin Medical University
Second Hospital of Shanxi Medical University
Jining Medical University
Yunyang Medical College
Wuhan No.1 Hospital
Shanxi Cardiovascular Hospital
China Three Gorges University, Yichang, China
First Affiliated Hospital of Guangxi Medical University
Xiangyang Central Hospital
Jingzhou Central Hospital
Tianyou Hospital Affiliated to Wuhan University of Science and Technology
Wuhan Pu-Ai Hospital

Investigators

  • Study Chair: Yu-Hua Liao, Docter, Wuhan Union Hospital, China

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

January 1, 2012

Primary Completion (Actual)

December 31, 2015

Study Completion (Actual)

September 30, 2016

Study Registration Dates

First Submitted

January 31, 2011

First Submitted That Met QC Criteria

February 10, 2011

First Posted (Estimate)

February 11, 2011

Study Record Updates

Last Update Posted (Actual)

August 29, 2017

Last Update Submitted That Met QC Criteria

August 26, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QLQX-DCM-01

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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