Chronic Thromboembolic Pulmonary Hypertension
Conditions
Interventions
Chronic Thromboembolic Pulmonary Hypertension
Hemodynamics
Magnetic Resonance Imaging
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Diagnosis of CTEPH or CTED (according to ESC/ERS guidelines (11)) - Scheduled for evaluation to determine possibility of PEA or BPA - Age > 18
Exclusion criteria
Exclusion criteria: - Pacemaker or other metal objects in the body - Severe claustrophobia - Severe renal insufficiency (eGFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters/endpoints: This is an observational study evaluating determinants of a persistent response to BPA or PEA. Main study parameter/endpoint is change in extracellular volume fraction after unloading of the RV after PEA or BPA. This is measured calculated from pre and post contrast T1 relaxation times measured by MR imaging. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change in RV function and volumes after PEA or BPA. This is measured by MR imaging (RV ejection fraction, end diastolic volume, end systolic volume) and right heart catheterization (end systolic elastance, RV-Arterial coupling) - Change in lung perfusion defects before and after PEA measured by MR perfusion - Change in serum levels of biomarkers of fibrosis and extracellular matrix - Change in platelet transcriptomes - Change in exercise capacity (peak oxygen uptake during cardiopulmonary exercise testing, or CPET, and distance walked in 6 minutes) and gas exchange during CPET (ventilatory efficiency, pulse oximetry) - Change in quality of life - Change in diffusion capacity | — |
Countries
Denmark
Outcome results
None listed