Objective: The objective of the study is to assess the structural and functional cardiac
effects of treatment with the beta 3 AR agonist Mirabegron in patients with chronic heart
failure.
Design: The investigators are planning a study aiming at establishing proof of concept that
treatment of patients with HF with Mirabegron has significant positive effects, as assessed
by clinical and biochemistry measurements, but not by hard endpoints. The investigators are
performing a combined dose-finding - chronic efficacy study.
The study is a randomized, placebo-controlled, double-blinded trial. The follow-up period is
6 months. 70 patients with chronic heart failure will be included.
Specific aims
1. Determine safety of administration of Mirabegron to patients with heart failure.
2. Determine if treatment with Mirabegron for 6 months induces beneficial cardiac
structural remodelling in patients with heart failure.
3. Determine if Mirabegron improves symptoms and exercise capacity as indicated by
questionnaires and 6 min walk test in patients with heart failure.
4. Determine effects of Mirabegron on cardiac conduction, repolarisation and rhythms and
arrhythmias in patients with heart failure.
5. Determine effects of Mirabegron on circulating biomarkers in patients with heart
failure.
Phase:
Phase 2
Details
Lead Sponsor:
Henning Bundgaard
Collaborators:
Department of Cardiology, Royal North Shore Hospital, Sydney, Australia Monash Center of Cardiovascular Research, Melbourne, Australia.