Impact of BPA in CTEPH on Cardiac and Pulmonary Physiology Assessed by CMR-derived 4D Flow Haemodynamics

ConditionCTEPH
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorKerckhoff Klinik

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 1 trial group
Group A: CTEPH patient

Trial outcomes

Primary outcomes

1

Impact of BPA on cardio-pulmonary vascular physiology

1a) Changes in right cardiac function (RV EF %)

Time frame
1 year
2

Impact of BPA on cardio-pulmonary vascular physiology

1b) Changes in cardiac function (RV GLS%)

Time frame
1 year
3

Impact of BPA on cardio-pulmonary vascular physiology

2a) Changes in pulmonary artery flow (peak flow m/s)

Time frame
1 year
4

Impact of BPA on cardio-pulmonary vascular physiology

2b) Changes in pulmonary artery flow (mean flow m/s)

Time frame
1 year

Secondary outcomes

1

Impact of BPA on cardio-pulmonary vascular physiology

1a) Change in LV tissue composition - T1 (ms)

Time frame
1 year
2

Impact of BPA on cardio-pulmonary vascular physiology

1b) Change in LV tissue composition - ECV (%)

Time frame
1 year
3

Impact of BPA on cardio-pulmonary vascular physiology

2\) Change in RA phasic function (%).

Time frame
1 year

Other outcomes

Sponsors and contacts

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