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 moderate to
severe chronic heart failure (LVEF<35%, NYHA III-IV).
The study is a randomized, placebo-controlled, double-blinded trial in two phases with two
hypotheses:
Chronic study - study A: Long-term treatment (3 months) with the β3 adrenergic receptor
agonist Mirabegron is beneficial in patients with moderate to severe human heart failure
Invasive study - Study B: Administration of Mirabegron in patients with heart failure leads
to an immediate increase in cardiac output at a constant or reduced left ventricular filling
pressure during submaximal exercise
Specific aims
1. Determine safety of administration of Mirabegron to patients with moderate to severe
heart failure.
2. Determine if treatment with Mirabegron for 3 months induces beneficial cardiac
structural remodelling in patients with moderate to severe heart failure. In an
open-label follow-up to determine the effects of Mirabegron after an extended duration
(a total of 12 months).
3. Determine if Mirabegron improves symptoms and exercise capacity as indicated by
questionnaires and 6 min walk test in patients with moderate to severe heart failure.
4. Determine effects of Mirabegron on cardiac conduction, repolarisation and rhythms and
arrhythmias in patients with moderate to severe heart failure.
5. Determine effects of Mirabegron on circulating biomarkers in patients with moderate to
severe heart failure.
6. Determine the immediate and short term haemodynamic effects of Mirabron as measured by
CT and invasively.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Henning Bundgaard
Collaborators:
Bispebjerg-Frederiksberg Hospital, Denmark Bornholm Hospital, Denmark Herlev Hospital Hillerød hospital, Denmark Hvidovre University Hospital Royal North Shore Hospital