Study of Qiliqiangxin Capsule to Treat Dilated Cardiomyopathy
NCT ID: NCT01293903
Last Updated: 2017-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
374 participants
INTERVENTIONAL
2012-01-31
2016-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Qiliqiangxin capsule
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
14 Years
70 Years
ALL
No
Sponsors
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Fudan University
OTHER
First Affiliated Hospital of Harbin Medical University
OTHER
First Affiliated Hospital Xi'an Jiaotong University
OTHER
Shandong Provincial Hospital
OTHER_GOV
The First Affiliated Hospital with Nanjing Medical University
OTHER
First Affiliated Hospital of Guangxi Medical University
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
Ministry of Science and Technology of the People´s Republic of China
OTHER_GOV
China National Center for Cardiovascular Diseases
OTHER_GOV
RenJi Hospital
OTHER
Second Affiliated Hospital of Xi'an Jiaotong University
OTHER
The Second Affiliated Hospital of Harbin Medical University
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Tongji Hospital
OTHER
Wuhan University
OTHER
Henan Provincial People's Hospital
OTHER
Jining Medical University
OTHER
Second Hospital of Shanxi Medical University
OTHER
Shanxi Cardiovascular Hospital
OTHER
Wuhan Pu-Ai Hospital
OTHER
Tianyou Hospital Affiliated to Wuhan University of Science and Technology
OTHER
Yunyang Medical College
OTHER
China Three Gorges University, Yichang, China
OTHER
Xiangyang Central Hospital
OTHER
Wuhan No.1 Hospital
OTHER
Jingzhou Central Hospital
OTHER
Huazhong University of Science and Technology
OTHER
Responsible Party
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Yu-Hua Liao
Professor and director of Institute of Cardiology, Union Hospital
Principal Investigators
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Yu-Hua Liao, Docter
Role: STUDY_CHAIR
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Locations
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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QLQX-DCM-01
Identifier Type: -
Identifier Source: org_study_id
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