Study of Qiliqiangxin Capsule to Treat Dilated Cardiomyopathy

Phase 4

Completed

• Conditions: Heart Failure; Dilated Cardiomyopathy
• Interventions: Drug: Placebo; Drug: Qiliqiangxin capsule

• Registration Number: NCT01293903
• Lead Sponsor: Huazhong University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-31
• Study First Submitted QC: 2011-02-10
• Study First Posted: 2011-02-11
• Study Start: 2012-01
• Primary Completion: 2015-12-31
• Study Completion: 2016-09-30
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-26
• Last Update Posted: 2017-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 374

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Qiliqiangxin capsule	Qiliqiangxin capsule	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China