Design of the ß3-Adrenergic Agonist Treatment in Chronic Pulmonary Hypertension Secondary to Heart Failure Trial.
JACC Basic Transl Sci
; 5(4): 317-327, 2020 Apr.
Article
em En
| MEDLINE
| ID: mdl-32368692
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 (ß3AR) 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 ß3AR agonist) in patients with CpcPH due to HF. The effect of ß3AR 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).
CCT, cardiac computed tomography; CMR, cardiac magnetic resonance; CpcPH, combined pre- and post-capillary pulmonary hypertension; ECG, electrocardiography; HF, heart failure; ITT, intention to treat; IpcPH, isolated post-capillary pulmonary hypertension; LHD, left heart disease; LV, left ventricular; LVEF, left ventricular ejection fraction; NT-proBNP, N-terminal prohormone of brain natriuretic peptide; NYHA, New York Heart Association; PAP, pulmonary artery pressure; PH, pulmonary hypertension; PP, Per protocol; PVR, pulmonary vascular resistance; RV, right ventricle; adrenoreceptors; cGMP, cyclic guanosine monophosphate; imaging; pulmonary hypertension; treatment; ß3AR, beta-3 adrenoreceptor
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2020
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Article