S92 Remote monitoring enabled evaluation of risk and physiological response to therapeutic escalation and clinical worsening in patients with pulmonary hypertension

Middleton, JT; Binmafooz, S; Zafar, Haroon; Patel, Junaid; Giri, Dilip; Battersby, Christian; Toshner, Mark; Reddy, Aravind; Lewis, Robin; Durrington, Charlotte; Swift, AJ; Condliffe, Robin; Elliot, Charlie; Hameed, Abdul; Thompson, Ron; Charalampopoulos, Athanasios; Kiely, DG; Rothman, AMK

doi:10.1136/thorax-2022-btsabstracts.98

Cited by 2 publications

(6 citation statements)

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“…Eligible patients will be implanted with CardioMEMS and Confirm Rx ICM devices using standard techniques and remote monitoring data collected using regulatory‐approved online portals 28 …”

Section: Methodsmentioning

confidence: 99%

“…9,[19][20][21][22] In patients with PAH, cardiopulmonary hemodynamics are closely associated with clinical outcomes, 7 and are affected by both diseases worsening and increase or withdrawal of therapy. 23,24 The development of minimally invasive technology that provides remote, daily measurement of cardiopulmonary hemodynamic parameters and physical activity may provide more comprehensive coverage of the effects of treatment on patients' daily functioning, allowing insight into the intervening periods between scheduled hospital visits. 25 Remote monitoring may provide benefits to both patients and care teams by allowing remote monitoring of efficacy following a treatment change.…”

Section: Introductionmentioning

confidence: 99%

“…Indeed, in patients with heart failure, remote, hemodynamic‐guided therapy has been demonstrated to reduce heart failure hospitalization, 26,27 and these studies have led to regulatory approval of pulmonary artery pressure (PAP) monitors. Furthermore, studies of patients with PAH implanted with a PAP monitor and an insertable cardiac monitor (ICM) demonstrated that clinically indicated therapeutic changes altered physiological parameters associated with mortality, indicating that early, remote assessment of clinical efficacy may be achieved using these devices 28 …”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

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,

Dick,

Battersby

et al. 2024

Pulm. circ.

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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.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

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,

Dick,

Battersby

et al. 2024

Pulm. circ.

View full text Add to dashboard Cite

show abstract

“…10,[19][20][21][22] In patients with PAH, cardiopulmonary haemodynamics are closely associated with clinical outcomes, 8 and are affected by both disease worsening and increase or withdrawal of therapy. 23,24 The development of minimally invasive technology that provides remote, daily measurement of cardiopulmonary haemodynamic parameters and physical activity may provide more comprehensive coverage of the effects of treatment on patients' daily functioning, allowing insight into the intervening periods between scheduled hospital visits. 25 Remote monitoring may provide benefit to both patients and care teams by allowing remote monitoring of efficacy following a treatment change.…”

Section: Phoenixmentioning

confidence: 99%

“…Furthermore, studies of patients with PAH implanted with a PAP monitor and an insertable cardiac monitor (ICM) demonstrated that clinically indicated therapeutic changes altered physiological parameters associated with mortality, indicating that early, remote assessment of clinical efficacy may be achieved using these devices. 28 CardioMEMS™ HF System (Abbott) is a wireless, CE-marked PAP monitor implanted at the time of right heart catheterisation to provide remote measurement of cardiopulmonary haemodynamics. CardioMEMS is approved for routine clinical practice in the USA and Europe, and to date over 30,000 of these monitors have been implanted.…”

Section: Phoenixmentioning

confidence: 99%

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

Varian,

Dick,

Battersby

et al. 2023

Preprint

View full text Add to dashboard Cite

Approved therapies for pulmonary arterial hypertension (PAH) mediate pulmonary vascular vasodilatation by targeting distinct biological pathways. Patients identified as intermediate-low risk, according to a four-strata risk assessment model, 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 opportunity for evaluation of individualised therapeutic effect. Traditionally, invasive/hospital-based investigations are required to comprehensively assess disease severity and demonstrate treatment benefit. Regulatory approved, minimally invasive monitors enable equivalent measurements to be obtained while patients are at home. In this 2x2 randomised 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 establishing 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 haemodynamics, 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.

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S92 Remote monitoring enabled evaluation of risk and physiological response to therapeutic escalation and clinical worsening in patients with pulmonary hypertension

Cited by 2 publications

References 0 publications

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

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

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

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