Personalized treatment for pulmonary arterial hypertension using remote monitoring
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)
This study tests whether using remote monitoring technology can help tailor drug treatments for people with pulmonary arterial hypertension to improve their health and quality of life.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Sheffield Teaching Hospitals NHS Foundation Trust Academic / other |
| Locations | 1 site (Sheffield) |
| Trial ID | NCT05825417 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of implantable and remote monitoring technology to personalize drug therapies for patients with pulmonary arterial hypertension (PAH). Participants will receive approved medical devices and undergo a 2x2 crossover study of established drugs, assessing their physiological responses and quality of life outcomes. The study aims to detect early indicators of clinical efficacy through remote monitoring compared to traditional measures like MRI and 6-minute walk tests. By comparing two therapeutic strategies within individual patients, the trial seeks to advance personalized medicine in PAH treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-80 with stable pulmonary arterial hypertension on guideline-recommended therapy and specific hemodynamic measurements.
Not a fit: Patients with PAH due to conditions like HIV, portal hypertension, or congenital heart disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and tailored treatment plans for patients with pulmonary arterial hypertension.
How similar studies have performed: Other studies have shown promise in using remote monitoring for chronic conditions, but this specific approach in PAH is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Sheffield
- Sheffield Teaching Hospitals NHS FT — Sheffield, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Alexander Rothman, MD / PhD — University of Sheffield
- Study coordinator: Jennifer Dick, PhD
- Email: jennifer.dick@sheffield.ac.uk
- Phone: +44 (0) 114 2159550
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.