Actively Recruiting

Age: 18Years +
All Genders
NCT04078243

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

Led by Sheffield Teaching Hospitals NHS Foundation Trust · Updated on 2025-06-04

120

Participants Needed

1

Research Sites

450 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of pulmonary hypertension (Group I, II, III and IV)
  • Age 18 years or older
  • Estimated glomerular filtration rate (eGFR) greater than 25
  • Body mass index (BMI) less than 35 (or equivalent)
  • Pulmonary artery (PA) branch diameter 7 mm or greater
  • Negative pregnancy test if female of childbearing age
  • Written, informed consent completed
  • Willingness to comply with study procedures
Not Eligible

You will not qualify if you...

  • Group IV pulmonary hypertension
  • Active infection
  • Pulmonary embolus (PE) or deep vein thrombosis (DVT)
  • Major cardiovascular event within the past 2 months
  • Cardiac resynchronisation therapy (CRT) device within the past 3 months
  • Mechanical right heart valve
  • Known coagulation disorder
  • Known hypersensitivity to aspirin or clopidogrel

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, United Kingdom, S5 7AU

Actively Recruiting

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Research Team

A

Alexander Rotherman

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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