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

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

Plain Language Summary

Simplified for easier understanding

This study is testing the feasibility of new clinical trial methods and technology for studying pulmonary hypertension (PH) — a condition where blood pressure in the arteries of the lungs is abnormally high. The study is not testing a specific drug but is testing whether new trial designs and digital tools can work effectively in this patient population. **You may be eligible if...** - You have been diagnosed with pulmonary hypertension (Groups I, II, III, or IV) - You are at least 18 years old - Your kidney function (eGFR) is above 25 - Your BMI is below 35 - You have adequate pulmonary artery size (branch at least 7mm) - You have a negative pregnancy test if you are of childbearing age - You are willing to comply with study requirements **You may NOT be eligible if...** - You have Group IV pulmonary hypertension (chronic thromboembolic pulmonary hypertension) - You have an active infection, blood clot (pulmonary embolism or DVT), or a major cardiovascular event within the past 2 months - You have a known clotting disorder or allergy to aspirin or clopidogrel - You have a mechanical heart valve or recently placed cardiac device Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECardioMEMS HF System

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Locations(1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, United Kingdom

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NCT04078243


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