About this trial
Patients with CTEPH referred for evaluation and conduction of BPA undergo standard of care diagnostic tests and treatment. This includes conventional echocardiographic, RHC and non-invasive (CT/CMR) or invasive (coronary angiography) coronary artery disease work-up. BPA will be conducted in generally 5 to 6 consecutive sessions. CMR will be performed prior to first and following the last intervention. Patient recruitment will be performed within 3 years, that is the last BPA session of the last patient in will have been performed at 3 years time.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient referred to BPA
clinical indication for CMR
capability to give informed consent
Disqualifiers
general: non-compliance, <18 years of age, pregnancy
contraindications for CMR (non-CMR compatible device, chronic kidney disease (eGFR <30ml/min), allergies (medications)
Trial population
All CTEPH patients to undergo BPA
Trial design
Case-only
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Impact of BPA on cardio-pulmonary vascular physiology
1a) Changes in right cardiac function (RV EF %)
Impact of BPA on cardio-pulmonary vascular physiology
1b) Changes in cardiac function (RV GLS%)
Impact of BPA on cardio-pulmonary vascular physiology
2a) Changes in pulmonary artery flow (peak flow m/s)
Impact of BPA on cardio-pulmonary vascular physiology
2b) Changes in pulmonary artery flow (mean flow m/s)
Secondary outcomes
Impact of BPA on cardio-pulmonary vascular physiology
1a) Change in LV tissue composition - T1 (ms)
Impact of BPA on cardio-pulmonary vascular physiology
1b) Change in LV tissue composition - ECV (%)
Impact of BPA on cardio-pulmonary vascular physiology
2\) Change in RA phasic function (%).
Sponsors and contacts
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