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 (QLQX-DCM)

NCT01293903 Phase 4 COMPLETED

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.

Details

Lead sponsor	Huazhong University of Science and Technology
Phase	Phase 4
Status	COMPLETED
Enrolment	374
Start date	2012-01
Completion	2016-09-30

Conditions

• Dilated Cardiomyopathy
• Heart Failure

Interventions

• Qiliqiangxin capsule
• Placebo

Primary outcomes

• 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

Countries

China