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Randomized controlled study of Norhintal and Enalapril in the treatment of Duchenne muscular dystrophy related cardiomyopathy

Randomized controlled study of Norhintal and Enalapril in the treatment of Duchenne muscular dystrophy related cardiomyopathy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075957
Enrollment
Unknown
Registered
2023-09-20
Start date
2023-09-25
Completion date
Unknown
Last updated
2024-04-29

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:Body weight 50kg: ARNI 97/103 mg/24h oral administration Bid
Group B:ACEI 0.2 mg/kg/24h orally administered Bid

Sponsors

West China Second University Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Written informed consent from the patient and/or legal guardian as required by the district or IRB; 2. Duchenne muscular dystrophy confirmed by genetic testing or muscle biopsy immunohistochemical testing; 3. The LVEF determined by CMR at the time of screening or within 1 month before randomization was >50%,and the CMR assessment was LGE positive; 4. The baseline status can be used to complete the cardiac magnetic resonance examination, and the baseline image quality meets the requirements for the evaluation and measurement of LGE volume, the main therapeutic effect evaluation index; 5. Aged >6 years and regularly treated with glucocorticoids for more than 6 months; He has not been regularly treated with ACEI/ARB drugs for a long time.

Exclusion criteria

Exclusion criteria: 1. Patients with contraindications and allergies to the use of ACEI/ARB/ sacubicyl valsartan, and allergic to magnetic resonance gadolinium contrast agents; 2. 30 days prior to screening exposure to any clinical trial drug (whether for DMD or not), (without limiting other drugs related to this study, such as BB, spironolactone, etc., to be corrected for statistical analysis); 3. There are arrhythmias or severe liver, kidney and lung diseases that require antiarrhythmic treatment; 4. Patients with other heart diseases, such as structural heart disease, cardiomyopathy, valvular heart disease, ischemic heart disease, etc; 5. Any other reason for which the investigator determines that the subject is unable to participate fully in the study and complete the study, including failure to comply with study procedures and treatments or any other related medical history or mental illness.

Design outcomes

Primary

MeasureTime frame
?LGE volume;

Secondary

MeasureTime frame
?LVEF;?GCS;?ECV;?GLS;? TnI;? NT-pro-BNP;

Countries

China

Contacts

Public ContactHuayan Xu

West China Second University Hospital, Sichuan University

xuhuayan2022.09_@scu.edu.cn+86 158 8240 8848

Outcome results

None listed

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