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The Preventive Efficacy of Carvedilol on Cardiac Dysfunction in Duchenne Muscular Dystrophy

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ClinicalTrials.gov Identifier: NCT00606775
Recruitment Status : Unknown
Verified December 2007 by Suzuka Hospital.
Recruitment status was:  Recruiting
First Posted : February 5, 2008
Last Update Posted : February 5, 2008
Sponsor:
Collaborator:
Nagoya University
Information provided by:
Suzuka Hospital

Tracking Information
First Submitted Date  ICMJE January 22, 2008
First Posted Date  ICMJE February 5, 2008
Last Update Posted Date February 5, 2008
Study Start Date  ICMJE December 2007
Estimated Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2008)
The suppression of minor cardiac damage indicated as elevation of plasma cTnI [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2008)
Left ventricular function deterioration assessed by echocardiography In-hospital mortality for cardiac dysfunction In-hospital mortality for any cause Overall mortality [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Preventive Efficacy of Carvedilol on Cardiac Dysfunction in Duchenne Muscular Dystrophy
Official Title  ICMJE Carvedilol for the Prevention of Minor Cardiac Damage and Cardiac Function in Duchenne Muscular Dystrophy
Brief Summary Purpose This cardiac dysfunction in patients with Duchenne muscular dystrophy is associated with minor cardiac damage as indicated by elevation of plasma cardiac troponin I (cTnI). The purpose of this study is to investigate whether the administration of Carvedilol can suppress the minor cardiac damage and prevent deterioration of cardiac function.
Detailed Description The life span in patients with Duchenne muscular dystrophy has been extending due to the development of artificial respiratory devices. According to that, the ratio of cardiac dysfunction as a cause of death has been increasing. This cardiac dysfunction was associated with minor cardiac damage as indicated by elevation of plasma cardiac troponin I (cTnI). Furthermore, and the detection rate of cTnI plasma as revealed to be correlated with the deterioration speed of LV dysfunction assessed by serial echocardiography measurements. Accordingly, if this minor cardiac damage is suppressed, it is postulated that the progression of cardiac dysfunction can be stopped. In the cases with ventricular arrhythmia and tachycardia, we found plasma cTnI became undetectable after administration of beta-blocker. Accordingly, we investigate whether administration of beta-blocker, carvedilol can persistently suppress the minor cardiac damage and lead to suppress the deterioration of LV function. Note that his study preventive study for preserved to moderate LV dysfunction and is not intended to the beta-blocker treatment for severe LV dysfunction. Because we assume that the mechanism of elevation of cTnI is different; spontaneous in preserved to mild LV dysfunction in patients but LV wall stress in severe LV dysfunction in patients with Duchenne muscular dystrophy.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Duchenne Muscular Dystrophy
  • Cardiomyopathies
Intervention  ICMJE Drug: Carvedilol
2.5-5mg/day
Other Name: Artist, Daich-Sankyo Co.Ltd
Study Arms  ICMJE
  • Experimental: Carvedilol
    Intervention: Drug: Carvedilol
  • No Intervention: Control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 4, 2008)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2012
Estimated Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Male patients with Duchenne muscular dystrophy are required to meet the following criteria:

  1. Aged 8 to 45 years
  2. Positive plasma cardiac troponin I (0.06ng/mL) at least 4 blood measurement in every 3 month.
  3. Left ventricular ejection fraction >30% by echocardiography assessment
  4. Written informed consent

Exclusion Criteria:

Patients with the following conditions will be excluded from the study:

  1. Left ventricular ejection fraction <30%
  2. No plasma cTnI elevation
  3. beta-blocker is already administered without measurement of plasma cTnI
  4. Contraindication against treatment with β blockers
  5. Any other serious disease that could potentially complicate the management and follow-up protocols
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 8 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00606775
Other Study ID Numbers  ICMJE TN1966220
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Takao Nishizawa, Department of Cardiology, Nagoya Universtiy Graduate School of Medicine
Study Sponsor  ICMJE Suzuka Hospital
Collaborators  ICMJE Nagoya University
Investigators  ICMJE
Principal Investigator: Takao Nishizawa, MD, PhD Department of Cardiology, Nagoya University Graduate School of Medicine
PRS Account Suzuka Hospital
Verification Date December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP