Pulmonary Hypertension: Intensification and Personalization of Combination Rx (PHoenix): A phase IV randomized trial for the evaluation of dose‐response and clinical efficacy of riociguat and selexipag using implanted technologies

Bibliographic Details
Title:	Pulmonary Hypertension: Intensification and Personalization of Combination Rx (PHoenix): A phase IV randomized trial for the evaluation of dose‐response and clinical efficacy of riociguat and selexipag using implanted technologies
Authors:	Frances Varian, Jennifer Dick, Christian Battersby, Stefan Roman, Jenna Ablott, Lisa Watson, Sarah Binmahfooz, Hamza Zafar, Gerry Colgan, John Cannon, Jay Suntharalingam, Jim Lordan, Luke Howard, Colm McCabe, John Wort, Laura Price, Colin Church, Neil Hamilton, Iain Armstrong, Abdul Hameed, Judith Hurdman, Charlie Elliot, Robin Condliffe, Martin Wilkins, Alastair Webb, David Adlam, Ray L. Benza, Kazem Rahimi, Mohadeseh Shojaei‐Shahrokhabadi, Nan X. Lin, James M. S. Wason, Alasdair McIntosh, Alex McConnachie, Jennifer T. Middleton, Roger Thompson, David G. Kiely, Mark Toshner, Alexander Rothman
Source:	Pulmonary Circulation, Vol 14, Iss 1, Pp n/a-n/a (2024)
Publisher Information:	Wiley, 2024.
Publication Year:	2024
Collection:	LCC:Diseases of the circulatory (Cardiovascular) system LCC:Diseases of the respiratory system
Subject Terms:	oral prostacyclin‐receptor agonist, remote monitoring, soluble guanylate‐cyclase stimulator, targeted therapy, Diseases of the circulatory (Cardiovascular) system, RC666-701, Diseases of the respiratory system, RC705-779
More Details:	Abstract Approved therapies for the treatment of patients with pulmonary arterial hypertension (PAH) mediate pulmonary vascular vasodilatation by targeting distinct biological pathways. International guidelines recommend that patients with an inadequate response to dual therapy with a phosphodiesterase type‐5 inhibitor (PDE5i) and endothelin receptor antagonist (ERA), are recommended to either intensify oral therapy by adding a selective prostacyclin receptor (IP) agonist (selexipag), or switching from PDE5i to a soluble guanylate‐cyclase stimulator (sGCS; riociguat). The clinical equipoise between these therapeutic choices provides the opportunity for evaluation of individualized therapeutic effects. Traditionally, invasive/hospital‐based investigations are required to comprehensively assess disease severity and demonstrate treatment benefits. Regulatory‐approved, minimally invasive monitors enable equivalent measurements to be obtained while patients are at home. In this 2 × 2 randomized crossover trial, patients with PAH established on guideline‐recommended dual therapy and implanted with CardioMEMS™ (a wireless pulmonary artery sensor) and ConfirmRx™ (an insertable cardiac rhythm monitor), will receive ERA + sGCS, or PDEi + ERA + IP agonist. The study will evaluate clinical efficacy via established clinical investigations and remote monitoring technologies, with remote data relayed through regulatory‐approved online clinical portals. The primary aim will be the change in right ventricular systolic volume measured by magnetic resonance imaging (MRI) from baseline to maximal tolerated dose with each therapy. Using data from MRI and other outcomes, including hemodynamics, physical activity, physiological measurements, quality of life, and side effect reporting, we will determine whether remote technology facilitates early evaluation of clinical efficacy, and investigate intra‐patient efficacy of the two treatment approaches.
Document Type:	article
File Description:	electronic resource
Language:	English
ISSN:	2045-8940
Relation:	https://doaj.org/toc/2045-8940
DOI:	10.1002/pul2.12337
Access URL:	https://doaj.org/article/c52635068f23481e953b6d13c82baf53
Accession Number:	edsdoj.52635068f23481e953b6d13c82baf53
Database:	Directory of Open Access Journals
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More Details
ISSN:	20458940
DOI:	10.1002/pul2.12337
Published in:	Pulmonary Circulation
Language:	English