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Early intervention for subclinical myocardial prevention of ACEI and beta-blocker in patients with Duchenne muscular dystrophy: a prospective multicenter randomized controlled clinical trial

Early intervention for subclinical myocardial prevention of ACEI and beta-blocker in patients with Duchenne muscular dystrophy: a prospective multicenter randomized controlled clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032525
Enrollment
Unknown
Registered
2020-05-01
Start date
2020-05-01
Completion date
Unknown
Last updated
2021-07-12

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

Conditions

Duchenne muscular dystrophy

Interventions

Group A:Perindopril
Group B:metoprolol
Group C:Perindopril and metoprolol

Sponsors

West China Second University Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
1 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. The patients with DMD were suspected to have progressive muscular dystrophy related diseases, and the mutations or deletions of DMD gene were found by further gene detection. 2. Patients who have received standard corticosteroid shock therapy but have not been treated with Angiotension, spironolactone, ARB and beta - blocker. 3. The renal function of the patients younger than 18 years old, male, was normal before MR examination (the clearance rate of serum creatinine was more than 120 mmol / L). 4. The patients who were assessed by Polaris scale and MRI of legs before the study were selected. The preliminary assessment showed that the skeletal muscle was obviously involved and the muscle strength was weakened. 5. In patients without contraindications of MR examination, myocardial abnormalities were found by T1 mapping and delayed enhancement, but the LVEF value was in the normal range. 6. Patients who understand the potential risks / benefits, agree to participate in the study, understand the study procedures, agree to complete the study follow-up and comply with the requirements of the study protocol.

Exclusion criteria

Exclusion criteria: 1. Patients with congenital heart disease and primary cardiomyopathy. 2. Patients with serious arrhythmia, frequent atrial fibrillation and serious image quality artifacts. 3. Patients with drug contraindications for the treatment of Angiotension inhibitors or spironolactones. 4. Patients who have participated in drug or biological preparation trials that may confuse the results of the study.

Design outcomes

Primary

MeasureTime frame
Medical Research Council Scale;Three functional tasks;cardiac function;Value of T1 mapping;Late delayed enhancement;Grading of leg steatosis;NYHA classification;

Secondary

MeasureTime frame
Markers of myocardial injury;electrocardiogram;myocardial perfusion;Myocardial enzyme;

Countries

China

Contacts

Public ContactYingkun Guo

West China Second Hospital of Sichuan University

gykpanda@163.com+86 18180609256

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026