Bisoprolol in DMD Early Cardiomyopathy

• Register: ClinicalTrials.gov
• Last refreshed on: 10 October 2022
• Main ID: NCT03779646
• Date of registration: 14/12/2018
• Prospective Registration: Yes
• Primary sponsor: Peking Union Medical College Hospital
• Public title: Bisoprolol in DMD Early Cardiomyopathy
• Scientific title: Bisoprolol for Early Cardiomyopathy in Duchenne Muscular Dystrophy: a Randomized, Controlled Trial
• Date of first enrolment: January 16, 2019
• Target sample size: 42
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03779646
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: Phase 2/Phase 3

Countries of recruitment

China

Contacts

• Name: Guo, Doctor

• Name: Xiaoxiao Guo, Dr.

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: 7 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Cardiomyopathy, Dilated

Duchenne Muscular Dystrophy

Intervention(s)

Drug: Bisoprolol Fumarate

Primary Outcome(s)

Calculate the change of left ventricle global longitudinal strain in cardiac MR [Time Frame: baseline and 12 months]

Secondary Outcome(s)

Change of the resting heart rate [Time Frame: baseline and 6months, 12 months]

Calculate the change of E/A ratio assessed by echocardiography [Time Frame: baseline and 12 months]

Calculate the change of ventricle late gadolinium enhancement area in cardia MR [Time Frame: baseline and 12 months]

Calculate the change of left ventricular ejection fraction in cardia MR [Time Frame: baseline and 12 months]

Calculate the change of the level of high-sensitivity cardiac troponin I [Time Frame: baseline and 6months, 12 months]

Calculate the change of the level of NT-proBNP [Time Frame: baseline and 6months, 12 months]

Secondary ID(s)

PekingUMCH-DMD

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Natural Science Foundation of China

Chinese Academy of Medical Sciences