Clinical trial NCT01293903: Study of Qiliqiangxin Capsule to Treat Dilated Cardiomyopathy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dilated Cardiomyopathy
Heart Failure
Keywords: Immunomodulation
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Fudan University
name: First Affiliated Hospital of Harbin Medical University
name: First Affiliated Hospital Xi'an Jiaotong University
name: Shandong Provincial Hospital
name: The First Affiliated Hospital with Nanjing Medical University
name: First Affiliated Hospital of Guangxi Medical University
name: The First Affiliated Hospital of Zhengzhou University
name: Ministry of Science and Technology of the People´s Republic of China
name: China National Center for Cardiovascular Diseases
name: RenJi Hospital
name: Second Affiliated Hospital of Xi'an Jiaotong University
name: The Second Affiliated Hospital of Harbin Medical University
name: Wuhan Union Hospital, China
name: Tongji Hospital
name: Wuhan University
name: Henan Provincial People's Hospital
name: Jining Medical University
name: Second Hospital of Shanxi Medical University
name: Shanxi Cardiovascular Hospital
name: Wuhan Pu-Ai Hospital
name: Tianyou Hospital Affiliated to Wuhan University of Science and Technology
name: Yunyang Medical College
name: China Three Gorges University, Yichang, China
name: Xiangyang Central Hospital
name: Wuhan No.1 Hospital
name: Jingzhou Central Hospital
First posted: 2011-02-11
Enrollment: 374
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The value of left ventricular end-diastolic dimension (LVEDd) and left ventricular ejection fraction(LVEF) confirmed by ultrasonic cardiogram (UCG)
timeFrame: 12 months after intervention
measure: The levels of serum representative cytokines detected by ELISA
timeFrame: 12 months after intervention
Secondary outcomes:
measure: Heart failure aggravation
timeFrame: 12 months after intervention
measure: All cause mortality
timeFrame: 12 months after intervention
measure: Sudden cardiac death
timeFrame: 12 months after intervention
measure: Stroke
timeFrame: 12 months after intervention
measure: The dynamic changes of serum representative cytokines detected by ELISA in the treatment group
timeFrame: 12 months after intervention
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Wuhan Union Hospital, China
name: Yu-Hua Liao, Docter
role: STUDY_CHAIR
References:
citation: Tang H, Zhong Y, Zhu Y, Zhao F, Cui X, Wang Z. Low responder T cell susceptibility to the suppressive function of regulatory T cells in patients with dilated cardiomyopathy. Heart. 2010 May;96(10):765-71. doi: 10.1136/hrt.2009.184945.
citation: Yuan J, Yu M, Lin QW, Cao AL, Yu X, Dong JH, Wang JP, Zhang JH, Wang M, Guo HP, Cheng X, Liao YH. Th17 cells contribute to viral replication in coxsackievirus B3-induced acute viral myocarditis. J Immunol. 2010 Oct 1;185(7):4004-10. doi: 10.4049/jimmunol.1001718. Epub 2010 Aug 27.
citation: Xiao H, Wang M, Du Y, Yuan J, Cheng X, Chen Z, Zou A, Wei F, Zhao G, Liao YH. Arrhythmogenic autoantibodies against calcium channel lead to sudden death in idiopathic dilated cardiomyopathy. Eur J Heart Fail. 2011 Mar;13(3):264-70. doi: 10.1093/eurjhf/hfq198. Epub 2010 Nov 2.
citation: Xiao H, Song Y, Li Y, Liao YH, Chen J. Qiliqiangxin regulates the balance between tumor necrosis factor-alpha and interleukin-10 and improves cardiac function in rats with myocardial infarction. Cell Immunol. 2009;260(1):51-5. doi: 10.1016/j.cellimm.2009.09.001. Epub 2009 Sep 11.