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

Recruitingn/aAges 18 Years - anyAllSheffield Teaching Hospitals NHS Foundation Trust
NCT04078243 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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.
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What it tests

  • CardioMEMS HF System
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Where

1 site
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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