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

Recruiting now

Conditions studied: Pulmonary Hypertension

In brief

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).

Key facts

Study ID

NCT04078243

Run by

Sheffield Teaching Hospitals NHS Foundation Trust

People needed

120

Starts

2020-01-21

Expected to finish

2028-09-06

Last updated by the study team

2025-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Sheffield Teaching Hospitals NHS Foundation Trust — Sheffield, South Yorkshire, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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