An observational study in Pulmonary Hypertension, sponsored by Sheffield Teaching Hospitals NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Sheffield Teaching Hospitals NHS Foundation Trust · Observational
Prospective, open-label, observational study to evaluate the safety and feasibility of using pulmonary artery pressure (PAP) monitors and wearable activity monitors in patients with pulmonary hypertension (PH).
This is a prospective, open-label, observational study, to evaluate the safety and feasibility of using pulmonary artery pressure monitors and wearable activity monitors in patients with pulmonary hypertension. We plan to correlate data from the PAP monitors with data from wearable activity monitors and review how often patients require ad hoc visits / medication changes as well as review the optimum dose of drug achieved / patient QoL / risk stratification and patient outcomes / mortality.
Suitable patients, with a confirmed diagnosis of PH on RHC, will be recruited from outpatient clinic or day-case and ward admissions by physicians or the research team. A face to face or telephone conversation will occur to discuss the study in detail and if the patient is willing they will be given / sent a patient information sheet (PIS) and be invited to attend a screening visit. If eligibility criteria are met, patients will complete a consent form and have their medical history reviewed including but not limited to past medical history, medication review, allergies and review of any hospital admissions in the previous 12 months. A clinical examination with observations including, but not limited to blood pressure, heart rate, oxygen saturations, respiratory rate, temperature, weight, height, body mass index (BMI) and assessment of NYHA class will be undertaken. Patients will be asked to perform a baseline six minute walk test, complete a quality of life questionnaire (EMPHASIS-10), 12-Lead ECG and baseline, clinically-indicated blood testing (including but not limited to FBC,UE,LFT, clotting screen, NT-Pro BNP) and imaging performed in clinical practise (TTE or cardiac MRI) will be reviewed. Eligible subjects will be scheduled for the Implant procedure. Subjects on anticoagulation therapy (e.g. warfarin) may be instructed by the Investigator to discontinue use 2 days prior to pressure sensor placement and may be bridged with low molecular weight heparin if required according to local trust standard of care bridging protocol.
If eligible, patients will then attend for their implantation visit and at this point undergo a RHC and a CardioMEMSTM sensor implant in the catheter laboratory. Baseline readings will be taken from the pressure monitor (including systolic, mean and diastolic PAP and cardiac output) and calibrated with readings taken at RHC. The patient's details will be uploaded to the CardioMEMSTM HF system, enabling remote monitoring of their heart failure device. Time will be spent educating and familiarising the patient with the home monitor system and contact details given in case any issues arise on discharge. Patients will be advised to submit one reading per day, preferably at the same time of day and in the same position i.e. lying down flat or at 45 degrees etc. Patients will be asked to monitor their symptom burden and to share this with the investigators.
The patient will also be given a Fitbit activity monitor and set up with an account that is accessible to patient and physician to allowing activity to be monitored. The research team will be able to continuously monitor data remotely from the CardioMEMSTM HF system and Fitbit platform.
Patients will attend for follow-up visits at 30 days and 1 year and will have their history reviewed and clinical examination and observations reassessed. At this point a repeat 6MWT, emPHasis-10 questionnaire, NYHA functional class and 12 Lead ECG will be undertaken as well as bloods testing and imaging as clinically indicated. Readings from the CardioMEMSTM HF system and Fitbit platform will also be reviewed and compared to the patients symptom diary.
In between visits patients will be contacted by telephone and invited for unscheduled visits if clinically indicated. Any clinically significant data or medication changes will be discussed or fed back to the clinical PH team in charge of the patients routine care as appropriate.
1,092 studies on the registry are indexed under Hypertension, Pulmonary; 244 are open to participants now.
This study's planned enrollment of 120 is close to the median of 110 across 381 observational studies indexed under Hypertension, Pulmonary.
Browse Hypertension, Pulmonary studies →Sheffield Teaching Hospitals NHS Foundation Trust is the lead sponsor of 214 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with a confirmed diagnosis of PH at right heart catheterisation (RHC) and New York Heart Association (NYHA) class III, prior admission for treatment of heart failure.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eligible patients will be recruited and will attend for the implantation in line with standard of care procedures. The patient's details will be uploaded to the CardioMEMS HF system, enabling remote monitoring of their heart failure device. The patient will also be given a Fitbit activity monitor and set up with an account that is accessible to patient and physician to allowing activity to be monitored. The research team will be able to continuously monitor data remotely from the CardioMEMS HF system and Fitbit platform.
Device: CardioMEMS HF System
The CardioMEMS HF System is the first and only FDA-approved wireless heart failure monitor. The system is a safe, reliable way to help your patients manage their heart failure.
Activity Monitors
To test the safety and feasibility of pressure monitoring and wearable activity monitors in patients with PH.
Time frame: Through study completion - 30/03/2024
Pulmonary Artery Pressure
To correlate Pulmonary Artery Pressure changes with outcome and activity data.
Time frame: Through study completion - 30/03/2024
Plan to share: No
Started Jan 2020 (actual). Primary completion is estimated for Jan 2028, 95 months after the start.
Of 143 non-industry observational studies under Hypertension, Pulmonary, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 167. This study's planned 95 months is above that.
Counting every sponsor, half of 168 studies reached it within 59 months; a quarter within 24 and three quarters within 107.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Sheffield Teaching Hospitals NHS Foundation Trust →