A double-blind randomised multi-centre, placebo-controlled trial of combined angiotensin converting enzyme-inhibitor and beta-blocker therapy in preventing the development of cardiomyopathy in genetically characterised males with Duchenne Muscular Dystrophy without echo-detectable left ventricular dysfunction

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN50395346

Enrollment

140

Registered

2007-08-13

Start date

2007-09-01

Completion date

Unknown

Last updated

2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Duchenne muscular dystrophy Nervous System Diseases Diseases of myoneural junction and muscle

Interventions

Presentation of Investigational Medicinal Product (IMP): Each participant will receive: 1. A one-month supply of perindopril 2 mg/bisoprolol 1.25 mg or placebo for the

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Boys aged 7 to 12 years 2. Genetically confirmed DMD with normal left ventricular function on trans-thoracic echocardiography (i.e., left ventricular ejection fraction by Simpson's biplane method greater than 55% [normal mean + SD = 63 + 5%], no global or regional wall motion abnormalities)

Exclusion criteria

Exclusion criteria: 1. Contraindication to ACE-inhibitor or beta-blocker therapy 2. Patients, whose initial echo is of insufficient quality to allow reliable measurements of ejection fraction or wall motion 3. Patients with abnormal echocardiograms at baseline 4. Patients with abnormal renal function (creatinine greater than upper limit of local laboratory range; typically greater than 120 mmol/l) or consistently abnormally high serum potassium level (K greater than upper limit of local laboratory range; typically 5 mmol/l)

Design outcomes

Primary

Measure	Time frame
Change in left ventricular ejection fraction by Simpson's biplane disk method, compared to baseline, after a minimum of two years of combination therapy or placebo. To assess robustness of ejection fraction result, similar comparisons will be made for parameters of left ventricular end-systolic volume and wall motion index.	—

Secondary

Measure	Time frame
1. Death from any cause 2. Development of symptoms and signs of congestive cardiac failure 3. Sufficient objective deterioration in cardiac function, without symptoms to make continued placebo therapy unethical Secondary outcomes are measured at baseline and 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 months.	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 10, 2026