Dilated Cardiomyopathy, Heart Failure
Conditions
Keywords
Immunomodulation
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.
Interventions
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.
DRUGPlacebo
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.
Sponsors
Fudan University
First Affiliated Hospital of Harbin Medical University
First Affiliated Hospital Xi'an Jiaotong University
Shandong Provincial Hospital
The First Affiliated Hospital with Nanjing Medical University
First Affiliated Hospital of Guangxi Medical University
The First Affiliated Hospital of Zhengzhou University
Ministry of Science and Technology of the People´s Republic of China
China National Center for Cardiovascular Diseases
RenJi Hospital
Second Affiliated Hospital of Xi'an Jiaotong University
The Second Affiliated Hospital of Harbin Medical University
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Tongji Hospital
Wuhan University
Henan Provincial People's Hospital
Jining Medical University
Second Hospital of Shanxi Medical University
Shanxi Cardiovascular Hospital
Wuhan Pu-Ai Hospital
Tianyou Hospital Affiliated to Wuhan University of Science and Technology
Yunyang Medical College
China Three Gorges University, Yichang, China
Xiangyang Central Hospital
Wuhan No.1 Hospital
Jingzhou Central Hospital
Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to 70 Years
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Sudden cardiac death | 12 months after intervention |
| Heart failure aggravation | 12 months after intervention |
| The dynamic changes of serum representative cytokines detected by ELISA in the treatment group | 12 months after intervention |
| Stroke | 12 months after intervention |
| All cause mortality | 12 months after intervention |
Countries
China
Outcome results
None listed