Trial intelligence / Profile preview

Bisoprolol for Early Cardiomyopathy in DMD

NCT03779646Phase 3

Key facts

Status: Unknown
Start: Jan 2019
Primary completion: Jul 2023
Countries: 1
Sponsor: Peking Union Medical College Hospital
Modality: Orthosteric Ligands

Drugs: bisoprolol
Conditions: dilated cardiomyopathy (DCM)

Overview

Phase 3, randomised, open-label trial of bisoprolol in dilated cardiomyopathy (DCM) (2 arms), sponsored by Peking Union Medical College Hospital. Primary endpoint: Change of left ventricle global longitudinal strain at 12 months. Status: unknown.

Design

2 arms

Study design: RandomizedOpen-label

Bisoprolol
Bisoprolol Fumarate added to background ACEI
Control
Standard of Care (ACEI only)

Who it enrols

Boys aged 7 years or older with Duchenne Muscular Dystrophy, on ACEI/ARB for >1 month, with confirmed myocardial damage (LGE) but preserved LVEF (>45%).

Endpoints

Primary

Change of left ventricle global longitudinal strain12 months

Secondary

Change of left ventricular ejection fraction12 months
Change of ventricle late gadolinium enhancement area12 months
Change of high-sensitivity cardiac troponin I12 months
Change of NT-proBNP12 months
Change of E/A ratio12 months
Change of resting heart rate12 months

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