Study of Qiliqiangxin Capsule to Treat Dilated Cardiomyopathy

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Brief Title

Study of Qiliqiangxin Capsule to Treat Dilated Cardiomyopathy

Official Title

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

Brief Summary

      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 Phase

Phase 4

Study Type

Interventional


Primary Outcome

The value of left ventricular end-diastolic dimension (LVEDd) and left ventricular ejection fraction(LVEF) confirmed by ultrasonic cardiogram (UCG)

Secondary Outcome

 Heart failure aggravation

Condition

Dilated Cardiomyopathy

Intervention

Qiliqiangxin capsule

Study Arms / Comparison Groups

 Qiliqiangxin capsule
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

374

Start Date

January 2012

Completion Date

September 30, 2016

Primary Completion Date

December 31, 2015

Eligibility Criteria

        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
      

Gender

All

Ages

14 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Yu-Hua Liao, Docter, , 

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT01293903

Organization ID

QLQX-DCM-01


Responsible Party

Principal Investigator

Study Sponsor

Huazhong University of Science and Technology

Collaborators

 Fudan University

Study Sponsor

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


Verification Date

August 2017