Study of Qiliqiangxin Capsule to Treat Dilated Cardiomyopathy

Study Overview
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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.

Official Title
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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

Conditions
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Dilated Cardiomyopathy, Heart Failure

Intervention / Treatment
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* Drug: Qiliqiangxin capsule
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Qiliqiangxin capsule<br> | Drug: Qiliqiangxin capsule<br>* 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.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunomodulation