PHoenix
Research type
Research Study
Full title
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)
IRAS ID
325120
Contact name
Alex Rothman
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
In this study, patients with established pulmonary arterial hypertension will be implanted with a pulmonary arterial pressure monitor and an insertable cardiac monitor so that remote monitoring can be undertaken. Patients will then enter into a crossover study of two approved drugs (one drug first which is then removed and followed by a second drug) during which standard clinical investigations will be undertaken at baseline and maximal therapy on each of the two drugs (screening + 4 assessment visits). The study design will provide multiple up-titrations (increases) of each of the drugs to investigate if they alter heart function and exercise capacity . It will then be established if the implanted monitors (which provide daily readings) are able to detect treatment effects of the different combination of medication earlier and more efficiently when compared to the standard measures (MRI, heart function parameters and exercise capacity) evaluated in clinic at 12-weeks only. Utimately, we aim to see if the comparison of the two therapeutic strategies in individual patients these remote monitoring devices can help personalise treatments for patients with PAH, and reduce the burden of hospital-based investigations.
REC name
North East - York Research Ethics Committee
REC reference
23/NE/0067
Date of REC Opinion
18 May 2023
REC opinion
Further Information Favourable Opinion