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MICA: Pulmonary Hypertension: intensification and personalisation of combination Rx (PHoenix)

In plain English

AI plain-English summary

Doctors currently have no way to tell whether a drug for pulmonary arterial hypertension is working in a patient without bringing them into hospital for invasive tests. This study will implant forty patients with approved medical monitors that transmit daily data on heart function, activity, and symptoms from home to care teams via secure online portals. Each patient will then try two different oral drugs in a randomised crossover design, allowing researchers to see—for the first time—which drug works for which person without repeated hospital visits. If successful, this approach could transform how new treatments for pulmonary hypertension are tested and prescribed. Instead of relying on hospital-based measurements that are months apart, drug developers could run faster, smaller trials using continuous home monitoring. Clinicians could match individual patients to the drug that actually improves their physiology, rather than switching therapies only after side effects or disease worsening force a change. The same remote-monitoring platform could eventually be applied to other chronic conditions where treatment decisions currently depend on infrequent, invasive assessments.

View original technical description
Pulmonary arterial hypertension (PAH) is a devastating disease driven by remodelling and constriction of the small blood vessels of the lungs. Approved therapies reduce constriction by targeting three distinct biological pathways. Therapies are changed due to side effects and/or disease worsening. However, due to the invasive, hospital-based investigations required to assess disease severity and demonstrate benefit of treatment, there is no way to match patients to drugs effective for their disease. Through an MRC Confidence-in-Concepts funded feasibility study we have developed the capacity to use regulatory approved, minimally-invasive monitors to make key measurements that allow assessment of disease severity and treatment effect while patients are at home. Data is relayed daily to care teams through regulatory approved, clinically used online portals, making early, remote evaluation of treatment benefit in an individual patient possible. In patients with pulmonary arterial hypertension (PAH) this study will: evaluate the capacity of implantable/remote technology for early evaluation of clinical efficacy and matching patients to drugs that work for them. Forty patients with PAH established on guideline recommended therapy will be implanted with approved medical devices and remote monitoring established. Physiology, activity and quality-of-life will be monitored during a randomised cross-over study of oral prostacyclin IP receptor agonist and soluble guanylate cyclase stimulator. The study will assess the physiology of therapeutic intensification and de-escalation in a manner previously unachievable. If successful, the technological approach will facilitate novel study designs in the area, providing a platform that has the potential to transform experimental medicine, therapeutic development and personalised medicine for patients with pulmonary hypertension.

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Researchers

Alex McConnachie (Co-Investigator)Alexander Rothman (Principal Investigator)Alistair Colin Church (Co-Investigator)David Kiely (Co-Investigator)James Wason (Co-Investigator)Jennifer Middleton (Co-Investigator)Mark Toshner (Co-Investigator)

Related Research

Grants with similar aims, by meaning.

A multicentre randomised cross-over trial of disease specific therapy in patients with Pulmonary Arterial Hypertension (PAH) implanted with pulmonary artery pressure and cardiac rhythm monitoring devices (CardioMEMS/ConfirmRx) (PHoenix)
A multicentre randomised cross-over trial of disease specific therapy in patients with Pulmonary Arterial Hypertension (PAH) implanted with pulmonary artery pressure and cardiac rhythm monitoring devices (CardioMEMS/Confirm Rx)
REvascularisation for heart failure with PReserved ejection fraction and Ischaemia: EValuation of Efficacy and mechanistic Description (REPRIEVED)
FIT PH: Feasibility of Novel Clinical Trial Infrastructure, Design and Technology for Early Phase Studies in Patients with Pulmonary Hypertension
Efficacy and safety of riociguat (MK-4836) in incipient pulmonary vascular disease as an indicator for early pulmonary arterial hypertensionDouble-blind, randomized, multicenter, multinational, placebo-controlled phase IIa study

Original classification

Research Grant

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