Heart failure & cardiomyopathiesRandomised controlled trial
Repurposing the β3-Adrenergic Receptor Agonist Mirabegron in Patients With Structural Cardiac Disease
- Randomised controlled trial
- phase 2b
- triple-blind
- placebo-controlled
- multicentre (10 academic hospitals, 8 European countries)
Authors' conclusion
In this study, mirabegron therapy had a neutral effect on LV mass or diastolic function over 12 months among patients who had structural heart disease with no or mild HF symptoms.
Study context
- Population
- Adults with left ventricular (LV) hypertrophy (LVMI ≥95 g/m² women, ≥115 g/m² men, or max wall thickness ≥13 mm) with no or mild heart failure (HF) symptoms (max NYHA class II)380 screened
- Participants
- 296 adults
- Comparison
- Mirabegron vs placebo
- Mirabegronn = 147
- Placebon = 149reference
- Primary endpoint
- LVMI by CMR and LV diastolic function (E/e' ratio by Doppler echocardiography)
- Follow-up
- 12 months
Primary result
As reported in the abstract
Mirabegron vs PlaceboDifference, g/m2 (95% CI)P value
LVMI increase; baseline and covariate-adjusted
1.3(−0.15 to 2.74)
P = 0.08Mirabegron vs PlaceboDifference (95% CI)P value
E/e' decrease; baseline and covariate-adjusted
−0.15(−0.69 to 0.4)
P = 0.60Safety
| Outcome | Mirabegron | Placebo |
|---|---|---|
| Adverse events | ||
| AEs | 213 in 82 patients | 215 in 88 patients |
| Serious AEs | 31 in 19 patients | 30 in 22 patients |
- Adverse events — Deaths during the trial
- 0
Original publication
Repurposing the β3-Adrenergic Receptor Agonist Mirabegron in Patients With Structural Cardiac Disease. JAMA Cardiol. Published 1 November 2023. doi:10.1001/jamacardio.2023.3003
Summarised from the published abstract; every number is checked against it