RecruitingPhase 4NCT05825417

Pulmonary Hypertension: Intensification and Personalisation of Combination Rx

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)


Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Enrollment

40 participants

Start Date

Jun 14, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to evaluate the capacity of implantable/remote technology for early evaluation of drug therapies in patients with pulmonary arterial hypertension (PAH). The main question it aims to answer is whether structured changes in clinical therapy will be detectable using implanted regulatory approved devices. Participants will will be implanted with approved medical devices and will enter into a study of approved drugs to assess physiology, activity and patient reported quality-of-life (QoL) outcomes. Researchers will compare two therapeutic strategies in each individual patient to see if the study design provides enough evidence to personalise drug treatment plans


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is exploring whether personalizing and intensifying medication combinations can improve outcomes for people with a specific type of high blood pressure in the lungs (pulmonary arterial hypertension, or PAH) who are not responding well enough to their current treatment. **You may be eligible if...** - You are 18–80 years old - You have been diagnosed with PAH (idiopathic, inherited, or related to drugs, toxins, or connective tissue disease) - You are already on a stable combination of PAH medications including an endothelin receptor antagonist and a PDE5 inhibitor - Your PAH is classified as WHO functional class III (significant symptoms limiting activity) - You can walk more than 50 metres in a 6-minute walk test - Your kidney function is adequate **You may NOT be eligible if...** - You have a history of unprovoked blood clots in the lungs - Your PAH is caused by HIV, liver disease, or congenital heart disease - You have pulmonary hypertension from other causes (heart disease, lung disease, etc.) - You have significant kidney disease - You have anaemia (low haemoglobin below 10 g/dL) - You have significant heart valve disease - You are allergic to aspirin, selexipag, or riociguat Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSelexipag

If Arm A - Up-titration to maximum tolerated dose followed by de-escalation If Arm B - Up-titration to maximum tolerated dose followed by observation, modification or transition at discretion of responsible care team where necessary.

DRUGRiociguat

If Arm A - Up-titration to maximum tolerated dose followed by de-escalation If Arm B - Up-titration to maximum tolerated dose followed by observation, modification or transition at discretion of responsible care team where necessary.

DEVICECardioMEMS pulmonary artery pressure monitor

Implantation and remote monitoring established with patient initiated daily readings

DEVICEConfirm Rx

Implantation and remote monitoring established with automated daily readings / downloads


Locations(1)

Sheffield Teaching Hospitals NHS FT

Sheffield, United Kingdom

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NCT05825417


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