RecruitingNCT04078243

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

Feasibility of Novel Clinical Trial Infrastructure, Design and Technology for Early Phase Studies in Patients With Pulmonary Hypertension.

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Enrollment

120 participants

Start Date

Jan 21, 2020

Study Type

OBSERVATIONAL

Conditions

Pulmonary Hypertension

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

Min Age: 18 Years

Inclusion Criteria8

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 Criteria8

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.

Interventions

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