At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-centre Randomized, Placebo-controlled Trial of Mirabegron, a New beta3-adrenergic Receptor Agonist on Left Ventricular Mass and Diastolic Function in Patients With Structural Heart Disease
In Brief
A Phase 2 clinical trial evaluating mirabegron, Echocardiography, and 5 other interventions for Hypertrophy, Left Ventricular. Completed, enrolled 296 participants across 10 sites in 8 countries.
Detailed Summary
This study will assess the efficacy of mirabegron, a new beta3-adrenergic receptor in the prevention of heart failure. This is a two armed, prospective, randomized, placebo-controlled, multi-centric european phase IIb trial with placebo and mirabegron distributed in a 1:1 fashion. The patients enrolled will have cardiac structural remodeling with or without symptoms of heart failure (maximum NYHA II). Patients will be monitored for change in left ventricular mass (assessed by cardiac MRI) and/or changes in diastolic function (assessed by echocardiography) after 12 months of treatment.
Study Details
Timeline
Interventions
50 mg daily during 12 months
Echocardiography
Cardiac MRI
Maximal exercise capacity
Blood sampling for study assessments and future exploratory studies.
EndoPAT assessment
PET scanning for beige/brown fat activation