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

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

This trial does not accept healthy volunteers

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 population

Patients with a confirmed diagnosis of PH at right heart catheterisation (RHC) and New York Heart Association (NYHA) class III, prior admission for treatment of heart failure.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • CardioMEMS HF System

    Device

    The CardioMEMS HF System is the first and only FDA-approved wireless heart failure monitor. The system is a safe, reliable way to help your patients manage their heart failure.

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: CardioMEMS HF System1 intervention

Trial outcomes

Primary outcomes

1

Activity Monitors

To test the safety and feasibility of pressure monitoring and wearable activity monitors in patients with PH.

Time frame
Through study completion - 30/03/2024

Secondary outcomes

1

Pulmonary Artery Pressure

To correlate Pulmonary Artery Pressure changes with outcome and activity data.

Time frame
Through study completion - 30/03/2024

Other outcomes

Sponsors and contacts

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