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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00606775
• Date of registration: 22/01/2008
• Prospective Registration: No
• Primary sponsor: Suzuka Hospital
• Public title: The Preventive Efficacy of Carvedilol on Cardiac Dysfunction in Duchenne Muscular Dystrophy
• Scientific title: Carvedilol for the Prevention of Minor Cardiac Damage and Cardiac Function in Duchenne Muscular Dystrophy
• Date of first enrolment: December 2007
• Target sample size: 60
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00606775
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: Phase 4

Countries of recruitment

Japan

Contacts

• Name: Takao Nishizawa, MD, PhD
• Affiliation: Department of Cardiology, Nagoya University Graduate School of Medicine

• Name: Takao Nishizawa, MD. PhD

• Name: Takao Nishizawa, MD,PhD

Key inclusion & exclusion 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 ß blockers

5. Any other serious disease that could potentially complicate the management and
follow-up protocols



Age minimum: 8 Years
Age maximum: 45 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Cardiomyopathies

Duchenne Muscular Dystrophy

Intervention(s)

Drug: Carvedilol

Primary Outcome(s)

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

Secondary Outcome(s)

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]

Secondary ID(s)

TN1966220

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Nagoya University