Back to resultsStudy of Qiliqiangxin Capsule to Treat Dilated Cardiomyopathy (QLQX-DCM)
Primary Purpose
Dilated Cardiomyopathy, Heart Failure
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Qiliqiangxin capsule
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dilated Cardiomyopathy focused on measuring Immunomodulation
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
Sites / Locations
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Qiliqiangxin capsule
Placebo
Arm Description
Outcomes
Primary Outcome Measures
The value of left ventricular end-diastolic dimension (LVEDd) and left ventricular ejection fraction(LVEF) confirmed by ultrasonic cardiogram (UCG)
The levels of serum representative cytokines detected by ELISA
Secondary Outcome Measures
Heart failure aggravation
All cause mortality
Sudden cardiac death
Stroke
The dynamic changes of serum representative cytokines detected by ELISA in the treatment group
Full Information
NCT ID
NCT01293903
First Posted
January 31, 2011
Last Updated
August 26, 2017
Sponsor
Huazhong University of Science and Technology
Collaborators
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, Wuhan Union Hospital, China, 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
1. Study Identification
Unique Protocol Identification Number
NCT01293903
Brief Title
Study of Qiliqiangxin Capsule to Treat Dilated Cardiomyopathy
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 31, 2015 (Actual)
Study Completion Date
September 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology
Collaborators
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, Wuhan Union Hospital, China, 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
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dilated Cardiomyopathy, Heart Failure
Keywords
Immunomodulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
374 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Qiliqiangxin capsule
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Qiliqiangxin capsule
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
The levels of serum representative cytokines detected by ELISA
Time Frame
12 months after intervention
Secondary Outcome Measure Information:
Title
Heart failure aggravation
Time Frame
12 months after intervention
Title
All cause mortality
Time Frame
12 months after intervention
Title
Sudden cardiac death
Time Frame
12 months after intervention
Title
Stroke
Time Frame
12 months after intervention
Title
The dynamic changes of serum representative cytokines detected by ELISA in the treatment group
Time Frame
12 months after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Hua Liao, Docter
Organizational Affiliation
Wuhan Union Hospital, China
Official's Role
Study Chair
Facility Information:
Facility Name
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
20448127
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.
Results Reference
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PubMed Identifier
20802148
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. 2011 Sep 15;187(6):3451-2. J Immunol. 2014 Dec 15;193(12):6208-9.
Results Reference
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PubMed Identifier
21044990
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.
Results Reference
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PubMed Identifier
19833326
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.
Results Reference
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Study of Qiliqiangxin Capsule to Treat Dilated Cardiomyopathy
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