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| Home > Articles > Published articles > β3 adrenergic agonist treatment in chronic pulmonary hypertension associated with heart failure (SPHERE-HF) : |
| Home > Articles > Published articles > β3 adrenergic agonist treatment in chronic pulmonary hypertension associated with heart failure (SPHERE-HF) : |
(Centro de Investigación Biomédica en Red en Enfermedades Cardiovasculares) (Centro de Investigación Biomédica en Red de Enfermedades Respiratorias) (IDIBAPS. Servei de Cardiologia) (Institut d'Investigació Biomèdica Sant Pau) (Hospital Universitario Puerta de Hierro Majadahonda (Madrid)) (Institut d'Investigació Biomèdica Sant Pau) (Centro de Investigación Biomédica en Red de Enfermedades Respiratorias)| Date: | 2023 |
| Abstract: | Aims: Pulmonary hypertension (PH) associated with left heart disease is an increasingly prevalent problem, orphan of targeted therapies, and related to a poor prognosis, particularly when pre- and post-capillary PH combine. The current study aimed to determine whether treatment with the selective β3 adrenoreceptor agonist mirabegron improves outcomes in patients with combined pre- and post-capillary PH (CpcPH). Methods and results: The β3 Adrenergic Agonist Treatment in Chronic Pulmonary Hypertension Secondary to Heart Failure (SPHERE-HF) trial is a multicentre, randomized, parallel, placebo-controlled clinical trial that enrolled stable patients with CpcPH associated with symptomatic heart failure. A total of 80 patients were assigned to receive mirabegron (50 mg daily, titrated till 200 mg daily, n = 39) or placebo (n = 41) for 16 weeks. Of them, 66 patients successfully completed the study protocol and were valid for the main analysis. The primary endpoint was the change in pulmonary vascular resistance (PVR) on right heart catheterization. Secondary outcomes included the change in right ventricular (RV) ejection fraction by cardiac magnetic resonance or computed tomography, other haemodynamic variables, functional class, and quality of life. The trial was negative for the primary outcome (placebo-corrected mean difference of 0. 62 Wood units, 95% confidence interval [CI] −0. 38, 1. 61, p = 0. 218). Patients receiving mirabegron presented a significant improvement in RV ejection fraction as compared to placebo (placebo-corrected mean difference of 3. 0%, 95% CI 0. 4, 5. 7%, p = 0. 026), without significant differences in other pre-specified secondary outcomes. Conclusions: SPHERE-HF is the first clinical trial to assess the potential benefit of β3 adrenergic agonists in PH. The trial was negative since mirabegron did not reduce PVR, the primary endpoint, in patients with CpcPH. On pre-specified secondary outcomes, a significant improvement in RV ejection fraction assessed by advanced cardiac imaging was found, without differences in functional class or quality of life. |
| Grants: | Instituto de Salud Carlos III INT19/00022 Instituto de Salud Carlos III PI17/00995 Instituto de Salud Carlos III PI20/00742 European Commission ERC-Consolidator 819775 Ministerio de Ciencia e Innovación PID2019-110369RB-I00 Agencia Estatal de Investigación CEX2020-001041-S |
| Note: | Altres ajuts: Fundació La Marató de TV3 (20151730-31-32); Comunidad de Madrid (S2017/BMD-3867 RENIM-CM). |
| Rights: | Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.  |
| Language: | Anglès |
| Document: | Article ; recerca ; Versió publicada |
| Subject: | Pulmonary hypertension ; Heart failure ; Mirabegron ; β3 adrenoreceptors |
| Published in: | European Journal of Heart Failure, Vol. 25 Núm. 3 (march 2023) , p. 373-385, ISSN 1879-0844 |
