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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Huazhong University of Science and Technology
Sponsor:
Collaborators:
Fudan University
Harbin Medical University
Xi’an Jiaotong University College of Medicine
Shandong Provincial Hospital
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Guangxi Medical University
The First Affiliated Hospital of Zhengzhou University
Shanxi Medical University
Ministry of Science and Technology of the People´s Republic of China
China National Center for Cardiovascular Diseases
Information provided by (Responsible Party):
Yu-Hua Liao, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01293903
First received: January 31, 2011
Last updated: September 4, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Dilated Cardiomyopathy
Heart Failure
Drug: Qiliqiangxin capsule
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Huazhong University of Science and Technology:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • The levels of serum representative cytokines detected by ELISA [ Time Frame: 12 months after intervention ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Heart failure aggravation [ Time Frame: 12 months after intervention ] [ Designated as safety issue: Yes ]
  • All cause mortality [ Time Frame: 12 months after intervention ] [ Designated as safety issue: Yes ]
  • Sudden cardiac death [ Time Frame: 12 months after intervention ] [ Designated as safety issue: Yes ]
  • Stroke [ Time Frame: 12 months after intervention ] [ Designated as safety issue: Yes ]
  • The dynamic changes of serum representative cytokines detected by ELISA in the treatment group [ Time Frame: 12 months after intervention ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: January 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   14 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01293903

Contacts
Contact: Yu-Hua Liao, Doctor +862785726376 liaoyh27@163.com
Contact: Miao Yu, master +8613995562434 yumiaodavid@126.com

Locations
China, Hubei
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430022
Contact: Yu-Hua Liao, Docter    +862785726376    liaoyh27@163.com   
Principal Investigator: Zhao-Hui Wang, Docter         
Principal Investigator: Jing Yuan, Docter         
Principal Investigator: Min Wang, Docter         
Sponsors and Collaborators
Huazhong University of Science and Technology
Fudan University
Harbin Medical University
Xi’an Jiaotong University College of Medicine
Shandong Provincial Hospital
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Guangxi Medical University
The First Affiliated Hospital of Zhengzhou University
Shanxi Medical University
Ministry of Science and Technology of the People´s Republic of China
China National Center for Cardiovascular Diseases
Investigators
Study Chair: Yu-Hua Liao, Docter Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  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
Study First Received: January 31, 2011
Last Updated: September 4, 2012
Health Authority: China: Ministry of Science and Technology

Keywords provided by Huazhong University of Science and Technology:
Immunomodulation

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

ClinicalTrials.gov processed this record on October 29, 2014