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

February 4, 2008 updated by: Suzuka Hospital

Carvedilol for the Prevention of Minor Cardiac Damage and Cardiac Function in Duchenne Muscular Dystrophy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Japan
    • Mie
      • Suzuka, Mie, Japan, 513-8501
        • Recruiting
        • Suzuka Hospial
        • Contact:
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Carvedilol
Drug: Carvedilol
2.5-5mg/day
Other Names:
  • Artist, Daich-Sankyo Co.Ltd
No Intervention: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The suppression of minor cardiac damage indicated as elevation of plasma cTnI
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suzuka Hospital

Collaborators

Nagoya University

Investigators

  • Principal Investigator: Takao Nishizawa, MD, PhD, Department of Cardiology, Nagoya University Graduate School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Anticipated)

December 1, 2008

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

January 22, 2008

First Submitted That Met QC Criteria

February 4, 2008

First Posted (Estimate)

February 5, 2008

Study Record Updates

Last Update Posted (Estimate)

February 5, 2008

Last Update Submitted That Met QC Criteria

February 4, 2008

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TN1966220

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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