Feasibility of Novel Clinical Trial Infrastructure, Design and Technology for Early Phase Studies in Patients With Pulmonary Hypertension.
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
RECRUITING
Sheffield
Contact Information
Primary
Alexander Rotherman
a.rothman@sheffield.ac.uk
0114 2509550
Time Frame
Start Date: 2020-01-21
Estimated Completion Date: 2028-09-06
Participants
Target number of participants: 120
Treatments
CardioMEMS HF System
Eligible patients will be recruited and will attend for the implantation in line with standard of care procedures. The patient's details will be uploaded to the CardioMEMS HF system, enabling remote monitoring of their heart failure device. The patient will also be given a Fitbit activity monitor and set up with an account that is accessible to patient and physician to allowing activity to be monitored. The research team will be able to continuously monitor data remotely from the CardioMEMS HF system and Fitbit platform.
Related Therapeutic Areas
Sponsors
Leads: Sheffield Teaching Hospitals NHS Foundation Trust