NCT01293903

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
374

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 11, 2011

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2016

Completed
Last Updated

August 29, 2017

Status Verified

August 1, 2017

Enrollment Period

4 years

First QC Date

January 31, 2011

Last Update Submit

August 26, 2017

Conditions

Dilated CardiomyopathyHeart Failure

Keywords

Immunomodulation

Outcome Measures

Primary Outcomes (2)

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

    12 months after intervention

  • The levels of serum representative cytokines detected by ELISA

    12 months after intervention

Secondary Outcomes (5)

  • Heart failure aggravation

    12 months after intervention

  • All cause mortality

    12 months after intervention

  • Sudden cardiac death

    12 months after intervention

  • Stroke

    12 months after intervention

  • The dynamic changes of serum representative cytokines detected by ELISA in the treatment group

    12 months after intervention

Study Arms (2)

Qiliqiangxin capsule

EXPERIMENTAL
Drug: Qiliqiangxin capsule

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Qiliqiangxin capsuleDRUG

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.

Qiliqiangxin capsule
PlaceboDRUG

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.

Placebo

Eligibility Criteria

Age14 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Dilated Cardiomyopathy (LVEF ≤ 45%)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Wuhan, Hubei, 430022, China

Location

Related Publications (4)

  • 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.

    PMID: 20448127BACKGROUND

  • 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.

    PMID: 20802148BACKGROUND

  • 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.

    PMID: 21044990BACKGROUND

  • 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.

    PMID: 19833326BACKGROUND

MeSH Terms

Conditions

Cardiomyopathy, DilatedHeart Failure

Interventions

qiliqiangxin

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesCardiomyopathiesLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Yu-Hua Liao, Docter

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and director of Institute of Cardiology, Union Hospital

Study Record Dates

First Submitted

January 31, 2011

First Posted

February 11, 2011

Study Start

January 1, 2012

Primary Completion

December 31, 2015

Study Completion

September 30, 2016

Last Updated

August 29, 2017

Record last verified: 2017-08

Locations

CN(1)