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RecruitingNCT04078243

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

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Trial Parameters

ConditionPulmonary Hypertension
SponsorSheffield Teaching Hospitals NHS Foundation Trust
Study TypeOBSERVATIONAL
PhaseN/A
Enrollment120
SexALL
Min Age18 Years
Max AgeN/A
Start Date2020-01-21
Completion2028-01-06
Interventions
CardioMEMS HF System

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Brief Summary

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).

Eligibility Criteria

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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