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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Suzuka Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Nagoya University
Information provided by:
Suzuka Hospital
ClinicalTrials.gov Identifier:
NCT00606775
First received: January 22, 2008
Last updated: February 4, 2008
Last verified: December 2007
  Purpose

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 Intervention Phase
Duchenne Muscular Dystrophy
Cardiomyopathies
Drug: Carvedilol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Carvedilol for the Prevention of Minor Cardiac Damage and Cardiac Function in Duchenne Muscular Dystrophy

Resource links provided by NLM:


Further study details as provided by Suzuka Hospital:

Primary Outcome Measures:
  • The suppression of minor cardiac damage indicated as elevation of plasma cTnI [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: December 2007
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Carvedilol Drug: Carvedilol
2.5-5mg/day
Other Name: Artist, Daich-Sankyo Co.Ltd
No Intervention: Control

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.

  Eligibility

Ages Eligible for Study:   8 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00606775

Contacts
Contact: Takao Nishizawa, MD,PhD +81-52-744-2150 nishizta@med.nagoya-u.ac.jp
Contact: Fumihiko Yasuma, MD,PhD +81-59-378-1321 yasuma@suzuka.go.jp

Locations
Japan
Suzuka Hospial Recruiting
Suzuka, Mie, Japan, 513-8501
Contact: Takao Nishizawa, MD. PhD    +81-52-744-2150    nishizta@med.nagoya-u.ac.jp   
Contact: Fumihiko Yasuma, MD. PhD    +81-593-78-0337    yasuma@suzuka.go.jp   
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
Investigators
Principal Investigator: Takao Nishizawa, MD, PhD Department of Cardiology, Nagoya University Graduate School of Medicine
  More Information

Publications:
Responsible Party: Takao Nishizawa, Department of Cardiology, Nagoya Universtiy Graduate School of Medicine
ClinicalTrials.gov Identifier: NCT00606775     History of Changes
Other Study ID Numbers: TN1966220
Study First Received: January 22, 2008
Last Updated: February 4, 2008
Health Authority: Japan: Institutional Review Board

Keywords provided by Suzuka Hospital:
Adrenergic beta-Antagonists
Duchenne Muscular Dystrophy
Cardiomyopathies
Troponin I

Additional relevant MeSH terms:
Muscular Dystrophy, Duchenne
Muscular Dystrophies
Cardiomyopathies
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, X-Linked
Genetic Diseases, Inborn
Heart Diseases
Cardiovascular Diseases
Adrenergic beta-Antagonists
Carvedilol
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists

ClinicalTrials.gov processed this record on July 10, 2014