Feasibility of Novel Clinical Trial Infrastructure, Design and Technology for Early Phase Studies in Patients With Pulmonary Hypertension (FIT-PH)

Study Overview
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Brief Summary
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Prospective, open-label, single centre, 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).

Detailed Description
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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.

Official Title
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Feasibility of Novel Clinical Trial Infrastructure, Design and Technology for Early Phase Studies in Patients With Pulmonary Hypertension.

Conditions
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Pulmonary Hypertension

Intervention / Treatment
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* Device: CardioMEMS HF System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of pulmonary hypertension (Group I,II,III and IV) Age 18 years Estimated glomerular filtration rate (eGFR) > 25 Body mass index (BMI) < 35 (or equivalent) Pulmonary artery (PA) branch 7mm Negative pregnancy test (If female of childbearing age) Written, informed consent completed Willingness of the patient to comply Exclusion Criteria: Group IV PH Active infection Pulmonary embolus (PE) or deep vein thrombosis (DVT) Major cardiovascular event within past 2 months Cardiac resynchronisation therapy (CRT) device within past 3 months Mechanical right heart valve Known coagulation disorder Known hypersensitivity to aspirin or clopidogrel.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CardioMEMS HF System<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity Monitors | To test the safety and feasibility of pressure monitoring and wearable activity monitors in patients with PH. | Through study completion - 30/03/2024 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary Artery Pressure | To correlate Pulmonary Artery Pressure changes with outcome and activity data. | Through study completion - 30/03/2024 |