Study of Qiliqiangxin Capsule to Treat Dilated Cardiomyopathy (QLQX-DCM)

Huazhong University of Science and Technology

Status and phase

Completed

Phase 4

Conditions

Heart Failure

Dilated Cardiomyopathy

Treatments

Drug: Placebo

Drug: Qiliqiangxin capsule

Study type

Interventional

Funder types

Other

Identifiers

NCT01293903

QLQX-DCM-01

Details and patient eligibility

About

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.

Enrollment

374 patients

Sex

All

Ages

14 to 70 years old

Volunteers

No Healthy Volunteers

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