Study of Qiliqiangxin Capsule to Treat Dilated Cardiomyopathy

NCT ID: NCT01293903

Last Updated: 2017-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

374 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Dilated Cardiomyopathy Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Qiliqiangxin capsule

Group Type EXPERIMENTAL

Qiliqiangxin capsule

Intervention Type DRUG

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.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role collaborator

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Guangxi Medical University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

Ministry of Science and Technology of the People´s Republic of China

OTHER_GOV

Sponsor Role collaborator

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role collaborator

RenJi Hospital

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Xi'an Jiaotong University

OTHER

Sponsor Role collaborator

The Second Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role collaborator

Tongji Hospital

OTHER

Sponsor Role collaborator

Wuhan University

OTHER

Sponsor Role collaborator

Henan Provincial People's Hospital

OTHER

Sponsor Role collaborator

Jining Medical University

OTHER

Sponsor Role collaborator

Second Hospital of Shanxi Medical University

OTHER

Sponsor Role collaborator

Shanxi Cardiovascular Hospital

OTHER

Sponsor Role collaborator

Wuhan Pu-Ai Hospital

OTHER

Sponsor Role collaborator

Tianyou Hospital Affiliated to Wuhan University of Science and Technology

OTHER

Sponsor Role collaborator

Yunyang Medical College

OTHER

Sponsor Role collaborator

China Three Gorges University, Yichang, China

OTHER

Sponsor Role collaborator

Xiangyang Central Hospital

OTHER

Sponsor Role collaborator

Wuhan No.1 Hospital

OTHER

Sponsor Role collaborator

Jingzhou Central Hospital

OTHER

Sponsor Role collaborator

Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Yu-Hua Liao

Professor and director of Institute of Cardiology, Union Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yu-Hua Liao, Docter

Role: STUDY_CHAIR

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Locations

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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status

Countries

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China

References

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Tang H, Zhong Y, Zhu Y, Zhao F, Cui X, Wang Z. Low responder T cell susceptibility to the suppressive function of regulatory T cells in patients with dilated cardiomyopathy. Heart. 2010 May;96(10):765-71. doi: 10.1136/hrt.2009.184945.

Reference Type BACKGROUND
PMID: 20448127 (View on PubMed)

Yuan J, Yu M, Lin QW, Cao AL, Yu X, Dong JH, Wang JP, Zhang JH, Wang M, Guo HP, Cheng X, Liao YH. Th17 cells contribute to viral replication in coxsackievirus B3-induced acute viral myocarditis. J Immunol. 2010 Oct 1;185(7):4004-10. doi: 10.4049/jimmunol.1001718. Epub 2010 Aug 27.

Reference Type BACKGROUND
PMID: 20802148 (View on PubMed)

Xiao H, Wang M, Du Y, Yuan J, Cheng X, Chen Z, Zou A, Wei F, Zhao G, Liao YH. Arrhythmogenic autoantibodies against calcium channel lead to sudden death in idiopathic dilated cardiomyopathy. Eur J Heart Fail. 2011 Mar;13(3):264-70. doi: 10.1093/eurjhf/hfq198. Epub 2010 Nov 2.

Reference Type BACKGROUND
PMID: 21044990 (View on PubMed)

Xiao H, Song Y, Li Y, Liao YH, Chen J. Qiliqiangxin regulates the balance between tumor necrosis factor-alpha and interleukin-10 and improves cardiac function in rats with myocardial infarction. Cell Immunol. 2009;260(1):51-5. doi: 10.1016/j.cellimm.2009.09.001. Epub 2009 Sep 11.

Reference Type BACKGROUND
PMID: 19833326 (View on PubMed)

Other Identifiers

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QLQX-DCM-01

Identifier Type: -

Identifier Source: org_study_id

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