Evaluating the accuracy of remote monitoring technology in capturing how patients respond to treatments for pulmonary arterial hypertension
| ISRCTN | ISRCTN18119805 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18119805 |
| ClinicalTrials.gov (NCT) | NCT05825417 |
| Integrated Research Application System (IRAS) | 325120 |
| Central Portfolio Management System (CPMS) | 55838 |
| Sponsor | Sheffield Teaching Hospitals NHS Foundation Trust |
| Funder | Medical Research Council |
- Submission date
- 18/03/2026
- Registration date
- 25/03/2026
- Last edited
- 10/04/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Pulmonary arterial hypertension (PAH) is a serious condition caused by the narrowing and stiffening of the small blood vessels in the lungs. This makes it harder for the heart to pump blood, leading to breathlessness and tiredness. While there are several effective treatments, doctors currently have to rely on hospital-based tests, some of which are invasive, to see how well a treatment is working. This means it can take a long time to find the best drug for an individual patient.
The aim of this study is to see if small, implanted devices can accurately monitor a patient’s health from their own home. We want to know if these devices can detect changes in lung pressure and heart function quickly after a patient starts or changes their medication. This could help doctors personalise treatment more effectively and reduce the need for hospital visits.
Who can participate?
Participants must be adults aged between 18 and 80 years who have been diagnosed with certain types of PAH. They should already be taking standard PAH medications but still have symptoms (known as World Health Organisation Functional Class III). Participants must be able to walk a minimum distance during a standard walking test. People who are pregnant or have certain other heart or lung conditions cannot take part.
What does the study involve?
All participants will have two small devices implanted:
1. CardioMEMS™: A tiny wireless sensor placed in the lung artery to measure blood pressure.
2. ConfirmRx™ (or similar): A small monitor placed under the skin of the chest to track heart rate and rhythm.
Participants are randomly assigned to a sequence of two different oral treatments (selexipag and riociguat). This is a cross-over study, meaning instead of one group getting Drug A and another group getting Drug B, every participant will have the opportunity to try both drugs at different times. This allows us to compare how the same person’s body responds to each treatment.
Throughout the study, the devices will send daily health data to the clinical team. Participants will also attend hospital visits for heart scans (MRI), walking tests, and blood tests, and will complete weekly questionnaires about their quality of life and any side effects.
What are the possible benefits and risks of participating?
Participants may benefit from closer monitoring of their condition and the opportunity to try different approved treatments to find what works best for them. The information gathered will also help improve care for other people with PAH in the future.
The risks include those associated with the minor surgical procedures to implant the devices, such as bruising, pain, or a small risk of infection or bleeding. There are also potential side effects from the medications used, which can include headaches, nausea, or jaw pain. The study team will monitor all participants closely for any problems.
Where is the study run from?
The study is managed by Sheffield Teaching Hospitals NHS Foundation Trust in collaboration with the University of Sheffield. Recruitment takes place at several specialist national pulmonary hypertension centres across the UK.
When is the study starting and how long is it expected to run for?
June 2023 to January 2027
Who is funding the study?
Medical Research Council (MRC) (UK)
Who is the main contact?
Prof. Alex Rothman, a.rothman@sheffield.ac.uk
Contact information
Principal investigator, Scientific
Royal Hallamshire Hospital, Sheffield Teaching Hospitals Foundation NHS Trust
Sheffield
S10 2JF
United Kingdom
| Phone | +44 (0)1142159521 |
|---|---|
| a.rothman@sheffield.ac.uk |
Public
Royal Hallamshire Hospital, Sheffield Teaching Hospitals Foundation NHS Trust
Sheffield
S10 2JF
United Kingdom
| Phone | +44 (0)1142159554 |
|---|---|
| s.rao@sheffield.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Active |
| Assignment | Crossover |
| Purpose | Device feasibility, Diagnostic, Health services research, Treatment |
| Scientific title | A multicentre randomised crossover trial of disease-specific therapy in patients with pulmonary arterial hypertension implanted with pulmonary artery pressure and cardiac rhythm monitoring devices (CardioMEMS/ConfirmRx) |
| Study acronym | PHoenix |
| Study objectives | |
| Ethics approval(s) |
Approved 01/05/2025, North East - York Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8079; york.rec@hra.nhs.uk), ref: 23/NE/0067 |
| Health condition(s) or problem(s) studied | Pulmonary arterial hypertension (PAH) |
| Intervention | In this study, patients established on guideline-recommended therapy will be implanted with devices and remote monitoring established. Patients will then enter into a 2 x 2 crossover study of approved drugs during which standard clinical investigations will be undertaken at baseline and maximal therapy on each drug. The crossover design will provide multiple increases and decreases of drugs known to alter haemodynamics and 6MWT. The study is powered to detect improvement in right ventricular stroke volume measured by MRI from baseline to maximal therapy for each drug. It will then be established if changes in remote-monitored measures provide an early indication of clinical efficacy when compared to the MRI, haemodynamics, NTproBNP and 6MWT made at 12 weeks. Remote measurement of haemodynamics during the two periods of de-escalation will inform understanding of physiology and inform clinical practice. The comparison of the two therapeutic strategies in individual patients in one study will facilitate novel clinical study designs and provide evidence for data-driven personalised medicine in the area. Participants will be randomised 1:1 to one of two treatment sequences (Arm A or Arm B) using a concealed, web-based randomisation system via the Zeesta eCRF portal. To ensure balanced groups across centers, a block randomisation method (block size of 4) stratified by study site will be used. Participants will undergo implantation of two monitoring devices: the CardioMEMS™ HF System (to monitor pulmonary artery pressure) and the Confirm Rx™ ICM (to monitor cardiac rhythm or equivalent device). Treatment arms: Arm A Treatment: Participants first receive selexipag (oral prostacyclin IP receptor agonist) added to their background therapy (PDE5i and ERA). This is followed by a "washout" period where they revert to baseline therapy before switching to riociguat (oral sGCS). Arm B Treatment: Participants follow the reverse sequence, receiving riociguat (which requires withdrawal of their background PDE5i) followed by selexipag. Method and frequency of administration 1. Selexipag (Uptravi): Administered as oral tablets twice daily, titrated from 200 mcg up to a maximum tolerated dose (max 1600 mcg) over the treatment period. 2. Riociguat (Adempas): Administered as oral tablets three times daily, titrated from 1 mg up to a maximum of 2.5 mg based on blood pressure. Duration and follow-up: Patients will complete two 12-week treatment periods (total 24 weeks) + reduce OPA and washout period. Clinical investigations (cardiac MRI, 6MWT, and NTproBNP) will be conducted at baseline and at the end of each 12-week maximal therapy period. Monitoring: Remote hemodynamic data will be captured daily throughout the entire study duration to evaluate the device’s efficacy in detecting physiological changes compared to standard clinical markers. |
| Intervention type | Drug/Device |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Selexipag, riociguat, ConfirmRx, CardioMEMS |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
Remote monitoring (continuous daily data): |
| Completion date | 31/01/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Total final enrolment | 42 |
| Key inclusion criteria | 1. Able to provide informed consent 2. Age 18-80 years 3. PAH which is idiopathic, heritable or associated with drugs, toxins or connective tissue disease 4. Stable PAH therapeutic regime comprising any combination of ERA and PDE5i for at least 1 month prior to screening (unless unable to tolerate therapy) 5. WHO functional class III 6. Resting mean pulmonary arterial pressure (mPAP) ≥20 mmHg, pulmonary capillary wedge pressure ≤15 mmHg, pulmonary vascular resistance ≥2 Wood Units measured by right heart catheterisation at time of diagnosis 7. Six-minute walk test (6MWT) >50 m at entry 8. Estimated glomerular filtration rate (eGFR) >30 ml/min/1.73 m² at entry (Appendix C) 9. Inadequate treatment response (clinically determined) |
| Key exclusion criteria | 1. Unable to provide informed consent 2. Pregnancy 3. Unprovoked pulmonary embolism (at any time) 4. Acute infection at time of screening (rescreening is permitted) 5. PAH due to human immunodeficiency virus, portal hypertension, schistosomiasis, congenital heart disease 6. Pulmonary hypertension due to left heart, lung, thromboembolic or unclear/multifactorial disease (Group II-V) 7. Unable to tolerate aspirin or P2Y12 inhibitor 8. Hypersensitivity to selexipag or riociguat 9. Clinically significant renal disease (eGFR ≤30 ml/min/1.73 m2) 10. Anaemia (haemoglobin <10 g/dl) 11. 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 |
| Date of first enrolment | 13/06/2023 |
| Date of final enrolment | 13/03/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
- Scotland
Study participating centres
Sheffield
S10 2JF
England
St Marys Hospital
South Wharf Road
London
W2 1BL
England
Clydebank
Clydebank
G81 4DY
Scotland
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
England
London
SW3 6NP
England
Pond Street
London
NW3 2QG
England
Cambridge Biomedical Campus
Cambridge
CB2 0AY
England
Bath
BA1 3NG
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan |
Editorial Notes
10/04/2026: Internal review.
23/03/2026: Study's existence confirmed by the North East - York Research Ethics Committee.
