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

• Status: Unknown status
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Suzuka Hospital
• Collaborator: Nagoya University
• Treatments: Carvedilol

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