Status:
UNKNOWN
Bisoprolol in DMD Early Cardiomyopathy
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
National Natural Science Foundation of China
Chinese Academy of Medical Sciences
Conditions:
Duchenne Muscular Dystrophy
Cardiomyopathy, Dilated
Eligibility:
MALE
7+ years
Phase:
PHASE2
PHASE3
Brief Summary
This study aimed to use cardiac magnetic resonance imaging (CMR) to evaluate the efficacy and safety of bisoprolol therapy for boys with Duchenne muscular dystrophy(DMD) and preserved ejection fractio...
Detailed Description
By the age of 20 years, almost all the patients with Duchenne muscular dystrophy(DMD) have experienced dilated cardiomyopathy (DCM), a condition that contributes significantly to their morbidity and m...
Eligibility Criteria
Inclusion
- Older than(including) 7 years old
- A definite diagnosis of DMD with muscle pathology confirming the expression of dystrophin lower than 5% and/or confirmed mutations in the DMD gene using a clinical accepted technique that completely defines the mutation.
- Using ACEI or ARB for more than 1 month
- Confirmed myocardial damage in one or more left ventricular segments evident by late gadolinium enhancement and preserved left ventricular systolic function(\>45%) by cine cardiac MR in 45 days
- Normal renal function
- Holter and blood pressure shows no contraindication of using bisoprolol
Exclusion
- Having metal implanted in body
- Having claustrophobia
- Allergic to gadolinium
- Complicated with other cardiovascular diseases
- Medical history or Holter show bradyarrhythmia like II/III degree atrioventricular block, sick sinus syndrome etc.
- Systolic blood pressure lower than 90mmHg or rest heart rate lower than 75bpm
- Having COPD or asthma history
- Having other complications: tumor, endocrine diseases
- Having beta blockers therapy
- Planned operation in the future 12 months
- Allergic to bisoprolol
Key Trial Info
Start Date :
January 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT03779646
Start Date
January 16 2019
End Date
July 1 2024
Last Update
September 28 2022
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China