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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 374
- Locations
- 1
- Primary Endpoint
- The value of left ventricular end-diastolic dimension (LVEDd) and left ventricular ejection fraction(LVEF) confirmed by ultrasonic cardiogram (UCG)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 14 Years to 70 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Qiliqiangxin capsule
Intervention: Qiliqiangxin capsule (Drug)
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
The value of left ventricular end-diastolic dimension (LVEDd) and left ventricular ejection fraction(LVEF) confirmed by ultrasonic cardiogram (UCG)
Time Frame: 12 months after intervention
The levels of serum representative cytokines detected by ELISA
Time Frame: 12 months after intervention
Secondary Outcomes
- 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)
Investigators
Yu-Hua Liao
Professor and director of Institute of Cardiology, Union Hospital
Huazhong University of Science and Technology