NCT02599480: Beta3_LVH

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

Completed Phase 2 Last updated 10 February 2025

What this trial tests

Phase 2 trial testing mirabegron in Hypertrophy, Left Ventricular in 296 participants. Completed in 16 February 2022.

Timeline

12 September 2016

Primary endpoint
26 February 2021

16 February 2022

Quick facts

Lead sponsor	Jean-Luc Balligand
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	296
Start date	12 September 2016
Primary completion	26 February 2021
Estimated completion	16 February 2022
Sites	10 locations across France, Italy, Greece, Belgium, United Kingdom, Germany, Poland, Portugal

Drugs / interventions tested

• mirabegron (MIRABEGRON) — full drug profile →
• Echocardiography
• Cardiac MRI
• Maximal exercise capacity
• Blood sampling — full drug profile →
• Endothelial function measurement
• 18FDG-PET

Conditions studied

• Hypertrophy, Left Ventricular — all drugs for Hypertrophy, Left Ventricular →

Sponsor

Jean-Luc Balligand

Who can join

Adults 18 to 90, any sex, with Hypertrophy, Left Ventricular. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Everything You Always Wanted to Know about β₃-AR * (* But Were Afraid to Ask).
   Schena G, Caplan MJ. · · 2019 · cited 107× · PMID 30995798 · DOI 10.3390/cells8040357
2. Therapeutic approaches in heart failure with preserved ejection fraction: past, present, and future.
   Wintrich J, Kindermann I, Ukena C, Selejan S, et al · · 2020 · cited 76× · PMID 32236720 · DOI 10.1007/s00392-020-01633-w
3. Targeting β3-Adrenergic Receptors in the Heart: Selective Agonism and β-Blockade.
   Cannavo A, Koch WJ. · · 2017 · cited 63× · PMID 28170359 · DOI 10.1097/fjc.0000000000000444
4. The Beta3 Adrenergic Receptor in Healthy and Pathological Cardiovascular Tissues.
   Michel LYM, Farah C, Balligand JL. · · 2020 · cited 58× · PMID 33276630 · DOI 10.3390/cells9122584
5. Adding insult to injury - Inflammation at the heart of cardiac fibrosis.
   Smolgovsky S, Ibeh U, Tamayo TP, Alcaide P. · · 2021 · cited 55× · PMID 33166625 · DOI 10.1016/j.cellsig.2020.109828
6. Mirabegron: potential off target effects and uses beyond the bladder.
   Dehvari N, da Silva Junior ED, Bengtsson T, Hutchinson DS. · · 2018 · cited 51× · PMID 29243229 · DOI 10.1111/bph.14121
7. The NO-cGMP-PKG Axis in HFpEF: From Pathological Mechanisms to Potential Therapies.
   Cai Z, Wu C, Xu Y, Cai J, et al · · 2023 · cited 33× · PMID 36818566 · DOI 10.14336/ad.2022.0523
8. Comparison of the antiremodeling effects of losartan and mirabegron in a rat model of uremic cardiomyopathy.
   Kovács ZZA, Szűcs G, Freiwan M, Kovács MG, et al · · 2021 · cited 20× · PMID 34471171 · DOI 10.1038/s41598-021-96815-5