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Recruiting NCT04078243

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

Conditions: Pulmonary Hypertension

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 120
Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Location: Sheffield Teaching Hospitals NHS Foundation Trust Sheffield South Yorkshire

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04078243). StuddyBuddy aggregates publicly available trial information.