Study of Qiliqiangxin Capsule to Treat Dilated Cardiomyopathy

Heart Failure Clinical Trial

— QLQX-DCM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01293903
• Other study ID #: QLQX-DCM-01
• Status: Completed
• Phase: Phase 4
• First received: January 31, 2011
• Last updated: August 26, 2017
• Start date: January 2012
• Est. completion date: September 30, 2016

Study information

• Verified date: August 2017
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 374
• Est. completion date: September 30, 2016
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Dilated Cardiomyopathy
• Heart Failure

Intervention

Drug:
• Qiliqiangxin capsule
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.
• Placebo
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.

Locations

Country	Name	City	State
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (27)

Lead Sponsor

Collaborator

Huazhong University of Science and Technology

China National Center for Cardiovascular Diseases, China Three Gorges University, Yichang, China, First Affiliated Hospital of Guangxi Medical University, First Affiliated Hospital of Harbin Medical University, First Affiliated Hospital Xi'an Jiaotong University, Fudan University, Henan Provincial Hospital, Jingzhou Central Hospital, Jining Medical University, Ministry of Science and Technology of the People´s Republic of China, RenJi Hospital, Second Affiliated Hospital of Xi'an Jiaotong University, Second Hospital of Shanxi Medical University, Shandong Provincial Hospital, Shanxi cardiovascular hospital, The First Affiliated Hospital of Zhengzhou University, The First Affiliated Hospital with Nanjing Medical University, The Second Affiliated Hospital of Harbin Medical University, Tianyou hospital affiliated to Wuhan University of Science and Technology, Tongji Hospital, Wuhan No.1 Hospital, Wuhan Pu-Ai Hospital, Wuhan Union Hospital, China, Wuhan University, Xiangyang Central Hospital, Yunyang Medical College

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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. — View 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. — View 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. Erratum in: J Immunol. 2014 Dec 15;193(12):6208-9. J Immunol. 2011 Sep 15;187(6):3451-2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The value of left ventricular end-diastolic dimension (LVEDd) and left ventricular ejection fraction(LVEF) confirmed by ultrasonic cardiogram (UCG)		12 months after intervention
Primary	The levels of serum representative cytokines detected by ELISA		12 months after intervention
Secondary	Heart failure aggravation		12 months after intervention
Secondary	All cause mortality		12 months after intervention
Secondary	Sudden cardiac death		12 months after intervention
Secondary	Stroke		12 months after intervention
Secondary	The dynamic changes of serum representative cytokines detected by ELISA in the treatment group		12 months after intervention