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Study of Qiliqiangxin Capsule to Treat Dilated Cardiomyopathy (QLQX-DCM)

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ClinicalTrials.gov Identifier: NCT01293903
Recruitment Status : Completed
First Posted : February 11, 2011
Last Update Posted : August 29, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Dilated Cardiomyopathy Heart Failure Drug: Qiliqiangxin capsule Drug: Placebo Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 374 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2012
Primary Completion Date : December 31, 2015
Study Completion Date : September 30, 2016


Arms and Interventions

Arm Intervention/treatment
Experimental: Qiliqiangxin capsule 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 Comparator: Placebo Drug: 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.


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. The levels of serum representative cytokines detected by ELISA [ Time Frame: 12 months after intervention ]

Secondary Outcome Measures :
  1. Heart failure aggravation [ Time Frame: 12 months after intervention ]
  2. All cause mortality [ Time Frame: 12 months after intervention ]
  3. Sudden cardiac death [ Time Frame: 12 months after intervention ]
  4. Stroke [ Time Frame: 12 months after intervention ]
  5. The dynamic changes of serum representative cytokines detected by ELISA in the treatment group [ Time Frame: 12 months after intervention ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01293903


Locations
China, Hubei
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Sponsors and Collaborators
Huazhong University of Science and Technology
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 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
Investigators
Study Chair: Yu-Hua Liao, Docter Wuhan Union Hospital, China
More Information

Publications:
Responsible Party: Yu-Hua Liao, Professor and director of Institute of Cardiology, Union Hospital, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT01293903     History of Changes
Other Study ID Numbers: QLQX-DCM-01
First Posted: February 11, 2011    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017

Keywords provided by Yu-Hua Liao, Huazhong University of Science and Technology:
Immunomodulation

Additional relevant MeSH terms:
Heart Failure
Cardiomyopathies
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
Cardiomegaly