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

Launched by SHEFFIELD TEACHING HOSPITALS NHS FOUNDATION TRUST · Sep 3, 2019

Keywords

ClinConnect Summary

The FIT-PH clinical trial is studying the safety and practicality of using special monitors to track heart and activity levels in patients with pulmonary hypertension (PH), a condition that affects blood flow in the lungs. This trial aims to see how well these monitors work in helping doctors understand the condition better and improve patient care. The study is currently recruiting participants aged 18 and older who have been diagnosed with different types of pulmonary hypertension and meet specific health criteria.

If you or a loved one are considering joining this trial, participants can expect to wear a device that monitors their pulmonary artery pressure and activity levels. To be eligible, you need to have a diagnosis of pulmonary hypertension and meet other health requirements, such as having a certain kidney function and a specific body weight. It’s important to note that individuals with certain recent health issues, such as major heart events or specific blood clot conditions, are not eligible to participate. Joining this study could provide valuable information for managing pulmonary hypertension while also contributing to research that may help others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.