Effects of cardioprotective therapy, carvedilol vs ramipril, in patients affected by Duchenne and Becker muscular dystrophy. Clinical significance and prognostic value of Cardiac Magnetic Resonance study. - ND

• Conditions: Duchenne and Becher muscular dystrophy; MedDRA version: 9.1Level: LLTClassification code 10013801Term: Duchenne muscular dystrophy

• Registration Number: EUCTR2008-007236-18-IT
• Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-11
• Last Update Posted: 5 August 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1) Immunohystochemical and molecular diagnosis of Duchenne and Becker muscular dystrophy. 2) Not evidence of clinical cardiomyopathy, i.e. no cardiac symptoms, normal ECG (see exclusion criteria for details), normal 2D-echocardiography with normal systolic, (left ventricular EF ≥ 55%, right ventricular EF ≥ 45% and absence of regional wall motion abnormalities, WMSI = 1) and diastolic function. 3) DMD patients treated with steroid therapy to modify the overall rate of muscle progression, are eligible to enter the study. 4) All DMD and BMD patients enrolled in this study are not treated with cardiological therapy (ACE-inhibitors, ARBs or Beta-Blockers). 5) Written informed consent to study participation (with serial visit, CMR and echocardiographic study) is required from all patients themselves, as well as their parent or guardian and healthy-control subjects.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Failure to obtain informed consent from patients, parents or guardians. 2) Any controindications to carvedilol or ramipril treatment. In particular all patients with bronchial asthma, diabetes, any degree of renal failure (all patients are required to have a normal creatinine level and clearance) . 3) DMD patients will be excluded if present ECGs anomalies as follows: tall R waves in the right precordial leads, with an abnormal R/S ratio, a deep and narrow Q wave greater than 4 mm over leads I, V5 and V6. in BMD patients ECG changes suggestive of ischemic heart disease, left bundle-branch block, atrial flutter/fibrillation, ventricular arrhythmias, any degree of atrioventricular block and left ventricular (LV) hypertrophy. Aspecific ST changes will be not considered as electrocardiographic exclusion criteria both in DMD and BMD patients. 4) In BMD patients exclusion criteria will be also hypertension and valvular heart disease other than trivial. 5) DMD and BMD patients requiring ventilatory (non-invasive or invasive) assistance. 6) Presence of systolic and/or diastolic dysfunction detected by 2D-Echocardiography. 7) Presence of any contraindications to CMR (including any history of claustrophobia). 8) Patients under the age of 2 years. 9) Renal failure, even mild. 10) Patient unable or unwilling to attend the follow-up and tests, in the opinion of local study principal investigator, (children not willing to perform CMR will not be enrolled).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified