Your browser doesn't support javascript.
loading
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.
Varian, Frances; Dick, Jennifer; Battersby, Christian; Roman, Stefan; Ablott, Jenna; Watson, Lisa; Binmahfooz, Sarah; Zafar, Hamza; Colgan, Gerry; Cannon, John; Suntharalingam, Jay; Lordan, Jim; Howard, Luke; McCabe, Colm; Wort, John; Price, Laura; Church, Colin; Hamilton, Neil; Armstrong, Iain; Hameed, Abdul; Hurdman, Judith; Elliot, Charlie; Condliffe, Robin; Wilkins, Martin; Webb, Alastair; Adlam, David; Benza, Ray L; Rahimi, Kazem; Shojaei-Shahrokhabadi, Mohadeseh; Lin, Nan X; Wason, James M S; McIntosh, Alasdair; McConnachie, Alex; Middleton, Jennifer T; Thompson, Roger; Kiely, David G; Toshner, Mark; Rothman, Alexander.
Afiliación
  • Varian F; Division of Clinical Medicine University of Sheffield Sheffield UK.
  • Dick J; Sheffield Pulmonary Vascular Disease Unit Sheffield Teaching Hospitals NHS Foundation Trust Sheffield UK.
  • Battersby C; Division of Clinical Medicine University of Sheffield Sheffield UK.
  • Roman S; Division of Clinical Medicine University of Sheffield Sheffield UK.
  • Ablott J; Sheffield Pulmonary Vascular Disease Unit Sheffield Teaching Hospitals NHS Foundation Trust Sheffield UK.
  • Watson L; Sheffield Pulmonary Vascular Disease Unit Sheffield Teaching Hospitals NHS Foundation Trust Sheffield UK.
  • Binmahfooz S; Sheffield Pulmonary Vascular Disease Unit Sheffield Teaching Hospitals NHS Foundation Trust Sheffield UK.
  • Zafar H; Division of Clinical Medicine University of Sheffield Sheffield UK.
  • Colgan G; Division of Clinical Medicine University of Sheffield Sheffield UK.
  • Cannon J; Sheffield Pulmonary Vascular Disease Unit Sheffield Teaching Hospitals NHS Foundation Trust Sheffield UK.
  • Suntharalingam J; Royal Free NHS Foundation Trust London UK.
  • Lordan J; Royal Papworth Hospital NHS Foundation Trust Cambridge UK.
  • Howard L; Royal United Hospitals Bath NHS Foundation Trust Bath UK.
  • McCabe C; Newcastle Hospitals NHS Foundation Trust Newcastle UK.
  • Wort J; Imperial College Healthcare NHS Trust London UK.
  • Price L; Royal Brompton and Harefield Guy's and St Thomas' NHS Foundation Trust London UK.
  • Church C; NHS Greater Glasgow and Clyde Glasgow UK.
  • Hamilton N; NHS Greater Glasgow and Clyde Glasgow UK.
  • Armstrong I; National Heart and Lung Institute, Faculty of Medicine, Imperial College London London UK.
  • Hameed A; Sheffield Pulmonary Vascular Disease Unit Sheffield Teaching Hospitals NHS Foundation Trust Sheffield UK.
  • Hurdman J; Sheffield Pulmonary Vascular Disease Unit Sheffield Teaching Hospitals NHS Foundation Trust Sheffield UK.
  • Elliot C; Sheffield Pulmonary Vascular Disease Unit Sheffield Teaching Hospitals NHS Foundation Trust Sheffield UK.
  • Condliffe R; Sheffield Pulmonary Vascular Disease Unit Sheffield Teaching Hospitals NHS Foundation Trust Sheffield UK.
  • Wilkins M; Sheffield Pulmonary Vascular Disease Unit Sheffield Teaching Hospitals NHS Foundation Trust Sheffield UK.
  • Webb A; Sheffield Pulmonary Vascular Disease Unit Sheffield Teaching Hospitals NHS Foundation Trust Sheffield UK.
  • Adlam D; National Heart and Lung Institute, Faculty of Medicine, Imperial College London London UK.
  • Benza RL; Wolfson Centre for Prevention of Stroke and Dementia University of Oxford Oxford UK.
  • Rahimi K; Cardiovascular Research Unit of Leicester Leicester UK.
  • Shojaei-Shahrokhabadi M; Mount Sinai Heart Icahn School of Medicine at Mount Sinai New York New York USA.
  • Lin NX; Deep Medicine, Nuffield Department of Women's and Reproductive Health University of Oxford Oxford UK.
  • Wason JMS; Biostatistics Research Group, Population Health Sciences Institute Newcastle University Newcastle upon Tyne UK.
  • McIntosh A; Biostatistics Research Group, Population Health Sciences Institute Newcastle University Newcastle upon Tyne UK.
  • McConnachie A; Biostatistics Research Group, Population Health Sciences Institute Newcastle University Newcastle upon Tyne UK.
  • Middleton JT; Robertson Centre for Biostatistics, School of Health and Wellbeing University of Glasgow Glasgow UK.
  • Thompson R; Robertson Centre for Biostatistics, School of Health and Wellbeing University of Glasgow Glasgow UK.
  • Kiely DG; Division of Clinical Medicine University of Sheffield Sheffield UK.
  • Toshner M; Sheffield Pulmonary Vascular Disease Unit Sheffield Teaching Hospitals NHS Foundation Trust Sheffield UK.
  • Rothman A; Division of Clinical Medicine University of Sheffield Sheffield UK.
Pulm Circ ; 14(1): e12337, 2024 Jan.
Article en En | MEDLINE | ID: mdl-38500737
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.
Palabras clave
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Pulm Circ Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Pulm Circ Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos