Assessment of Efficacy of Mirabegron, a New beta3-adrenergic Receptor in the Prevention of Heart Failure

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.

Conditions

• Hypertrophy, Left Ventricular

Interventions

DRUG

mirabegron

50 mg daily during 12 months

PROCEDURE

Echocardiography

Echocardiography

PROCEDURE

Cardiac MRI

Cardiac MRI

PROCEDURE

Maximal exercise capacity

Maximal exercise capacity

PROCEDURE

Blood sampling

Blood sampling for study assessments and future exploratory studies.

PROCEDURE

Endothelial function measurement

EndoPAT assessment

RADIATION

18FDG-PET

PET scanning for beige/brown fat activation

Sponsors & Collaborators

• Zentrum für Klinische Studien Leipzig

  collaborator OTHER

• European Clinical Research Infrastructure Network

  collaborator OTHER

• European Society of Cardiology

  collaborator NETWORK

• European Commission

  collaborator OTHER

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  collaborator OTHER

• Northern Lisbon Hospital Center

  collaborator OTHER

• University of Athens

  collaborator OTHER

• Center for Cardiovascular Research Berlin

  collaborator OTHER

• Wroclaw Medical University

  collaborator OTHER

• Papa Giovanni XXIII Hospital

  collaborator OTHER

• Nantes University Hospital

  collaborator OTHER

• University Medical Center Goettingen

  collaborator OTHER

• University of Oxford

  collaborator OTHER

• Jean-Luc Balligand

  lead OTHER

Principal Investigators

• Jean-Luc Balligand, Prof. MD · Université Catholique de Louvain

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-09-12

Primary Completion

2021-02-26

Completion

2022-02-16

Countries

• Belgium
• France
• Germany
• Greece
• Italy
• Poland
• Portugal
• United Kingdom

Study Locations