Status:
RECRUITING
Feasibility of Novel Clinical Trial Infrastructure, Design and Technology for Early Phase Studies in Patients With Pulmonary Hypertension (FIT-PH)
Lead Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Conditions:
Pulmonary Hypertension
Eligibility:
All Genders
18+ years
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 hyperten...
Detailed Description
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 hyp...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 21 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 6 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04078243
Start Date
January 21 2020
End Date
September 6 2028
Last Update
June 4 2025
Active Locations (1)
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1
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, United Kingdom, S5 7AU