Feasibility of Novel Clinical Trial Infrastructure, Design and Technology for Early Phase Studies in Patients With Pulmonary Hypertension (FIT-PH)
Recruiting · NCT04078243 · Observational (researchers observe without assigning treatment) · Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
View the official record on ClinicalTrials.gov →Interventions studied
CardioMEMS HF System
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
1 location listed.
- Sheffield Teaching Hospitals NHS Foundation Trust - Sheffield, South Yorkshire, United Kingdom