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

ConditionPulmonary Hypertension

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorSheffield Teaching Hospitals NHS Foundation Trust

About this trial

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

Qualifiers

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)

Disqualifiers

Group IV PH

Active infection

Pulmonary embolus (PE) or deep vein thrombosis (DVT)

Major cardiovascular event within past 2 months

Trial design

Treatments tested in this trial

CardioMEMS HF System

Treatment groups

120 Participants

are divided into 1 treatment group

Sponsors and collaborators

Sheffield Teaching Hospitals NHS Foundation Trust

Lead sponsor

Source ClinicalTrials.gov