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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Nagoya University
Information provided by:
Suzuka Hospital

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.

Condition or disease Intervention/treatment Phase
Duchenne Muscular Dystrophy Cardiomyopathies Drug: Carvedilol Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Carvedilol for the Prevention of Minor Cardiac Damage and Cardiac Function in Duchenne Muscular Dystrophy
Study Start Date : December 2007
Estimated Primary Completion Date : December 2008
Estimated Study Completion Date : December 2012

Arm Intervention/treatment
Experimental: Carvedilol Drug: Carvedilol
Other Name: Artist, Daich-Sankyo Co.Ltd

No Intervention: Control

Primary Outcome Measures :
  1. The suppression of minor cardiac damage indicated as elevation of plasma cTnI [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00606775

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Contact: Takao Nishizawa, MD,PhD +81-52-744-2150
Contact: Fumihiko Yasuma, MD,PhD +81-59-378-1321

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Suzuka Hospial Recruiting
Suzuka, Mie, Japan, 513-8501
Contact: Takao Nishizawa, MD. PhD    +81-52-744-2150   
Contact: Fumihiko Yasuma, MD. PhD    +81-593-78-0337   
Sub-Investigator: Fumihiko Yasuma, MD, PhD         
Sub-Investigator: Toshimitsu Mori, MD         
Sub-Investigator: Motoko Sakai, MD, PhD         
Sub-Investigator: Satoshi Kuru, MD, PhD         
Sub-Investigator: Seigo Kimura, MD         
Sub-Investigator: Takuya Tamura, MD         
Sub-Investigator: Kentaro Sahashi, MD         
Sub-Investigator: Rei Shibata, MD, PhD         
Sub-Investigator: Taiki Ohashi, MD         
Sponsors and Collaborators
Suzuka Hospital
Nagoya University
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Principal Investigator: Takao Nishizawa, MD, PhD Department of Cardiology, Nagoya University Graduate School of Medicine
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Responsible Party: Takao Nishizawa, Department of Cardiology, Nagoya Universtiy Graduate School of Medicine Identifier: NCT00606775    
Other Study ID Numbers: TN1966220
First Posted: February 5, 2008    Key Record Dates
Last Update Posted: February 5, 2008
Last Verified: December 2007
Keywords provided by Suzuka Hospital:
Adrenergic beta-Antagonists
Duchenne Muscular Dystrophy
Troponin I
Additional relevant MeSH terms:
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Muscular Dystrophies
Muscular Dystrophy, Duchenne
Heart Diseases
Cardiovascular Diseases
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Protective Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists