Key result
The SPHERE-HF trial is designed to evaluate whether 16 weeks of mirabegron treatment reduces pulmonary vascular resistance compared to placebo in patients with combined pre- and post-capillary pulmonary hypertension secondary to heart failure.
Why the study?
Combined pre- and post-capillary pulmonary hypertension is a common complication of heart failure linked to poor prognosis, but currently lacks approved specific therapies.
Does mirabegron improve pulmonary vascular resistance in patients with combined pre- and post-capillary pulmonary hypertension secondary to heart failure?
RCT (n=80)
Double-blind
Randomly selected block sizes stratified by center
Yes
Does mirabegron improve pulmonary vascular resistance in patients with combined pre- and post-capillary pulmonary hypertension secondary to heart failure?
The SPHERE-HF trial protocol outlines a phase II study to determine if the beta-3 adrenergic agonist mirabegron improves pulmonary vascular resistance and right ventricular performance in patients with combined pre- and post-capillary pulmonary hypertension secondary to heart failure.
Combined pre-and post-capillary hypertension (CpcPH) is a relatively common complication of heart failure (HF) associated with a poor prognosis. Currently, there is no specific therapy approved for this entity. Recently, treatment with beta-3 adrenergic receptor (β3AR) agonists was able to improve pulmonary hemodynamics and right ventricular (RV) performance in a translational, large animal model of chronic PH. The authors present the design of a phase II randomized clinical trial that tests the benefits of mirabegron (a clinically available β3AR agonist) in patients with CpcPH due to HF. The effect of β3AR treatment will be evaluated on pulmonary hemodynamics, as well as clinical, biochemical, and advanced cardiac imaging parameters. (Beta3 Agonist Treatment in Chronic Pulmonary Hypertension Secondary to Heart Failure [SPHERE-HF]; NCT02775539).
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García‐Lunar et al. (2020) conducted an RCT in Combined pre- and post-capillary pulmonary hypertension secondary to heart failure (n=80). Mirabegron vs. Placebo was evaluated on Change in pulmonary vascular resistance (PVR) from baseline to week 16. The SPHERE-HF trial is designed to evaluate whether 16 weeks of mirabegron treatment reduces pulmonary vascular resistance compared to placebo in patients with combined pre- and post-capillary pulmonary hypertension secondary to heart failure.
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