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NCT Number: NCT01293903

Study of Qiliqiangxin Capsule to Treat Dilated Cardiomyopathy

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.

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Key information

Conditions

Dilated Cardiomyopathy Cardiomegaly Cardiomyopathies Cardiomyopathy, Dilated Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heart Diseases Heart Failure Laminopathies

Age range

14 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Qiliqiangxin capsule

Drug

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

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Collaborators

  • China National Center for Cardiovascular Diseases
  • China Three Gorges University, Yichang, China
  • First Affiliated Hospital Xi'an Jiaotong University
  • First Affiliated Hospital of Guangxi Medical University
  • First Affiliated Hospital of Harbin Medical University
  • Fudan University
  • Henan Provincial People's 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
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Wuhan No.1 Hospital
  • Wuhan Pu-Ai Hospital
  • Wuhan University
  • Xiangyang Central Hospital
  • Yunyang Medical College

Registry information

Official study 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

Acronym: QLQX-DCM

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Feb 11, 2011
Registry last updated
Aug 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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