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