Pulmonary Hypertension: Intensification and Personalisation of Combination Rx

• Status: Not yet recruiting
• Trial end date: 2026-01-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
• Collaborators: University of Cambridge; University of Glasgow; University of Newcastle Upon-Tyne; University of Sheffield
• Treatments: Riociguat; Selexipag

Criteria

Inclusion Criteria:

• Able to provide informed consent

• Age 18-80 years

• PAH which is idiopathic, heritable or associated with drugs, toxins or connective tissue disease

• Stable PAH therapeutic regime comprising any combination of ERA and PDE5i for at least 1 month prior to screening (unless unable to tolerate therapy)

• WHO functional class III

• Resting mPAP ≥20 mmHg, pulmonary capillary wedge pressure ≤15 mmHg, pulmonary vascular resistance ≥2 Wood Units measured by right heart catheterisation at time of diagnosis

• 6MWT >50m at entry

• Estimated glomerular filtration rate (eGFR)>30 ml/min/1.73 m² at entry (Appendix C)

• Inadequate treatment response (clinically determined)

Exclusion Criteria:

• Unable to provide informed consent

• Pregnancy

• Unprovoked pulmonary embolism (at any time)

• Acute infection at time of screening (rescreening is permitted)

• PAH due to human immunodeficiency virus, portal hypertension, schistosomiasis, congenital heart disease

• Pulmonary hypertension due to left heart, lung, thromboembolic or unclear/multifactorial disease (Group II-V)

• Unable to tolerate aspirin or P2Y12 inhibitor

• Hypersensitivity to selexipag or riociguat

• Clinically-significant renal disease (eGFR≤30 ml/min/1.73m2)

• Anaemia (haemoglobin <10 g/dl)

• Left-sided heart disease and/or clinically significant cardiac disease, including but not limited to any of the following: aortic or mitral valve disease greater than mild aortic insufficiency; mild aortic stenosis; mild mitral stenosis; or moderate mitral regurgitation