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

Impact of Balloon Pulmonary Angioplasty in CTEPH on Cardiac and Pulmonary Physiology as Assessed by State-of-the-art Cardiovascular Magnetic Resonance 4D Flow Haemodynamics

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07299227

Enrollment

Registered

2025-12-23

Start date

2025-09-01

Completion date

2028-12-31

Last updated

2025-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CTEPH

Keywords

CTEPH, CMR, 4D flow

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Inclusion criteria

* Patient referred to BPA * clinical indication for CMR * capability to give informed consent

Exclusion criteria

* general: non-compliance, \<18 years of age, pregnancy * contraindications for CMR (non-CMR compatible device, chronic kidney disease (eGFR \<30ml/min), allergies (medications)

Design outcomes

Primary

Measure	Time frame	Description
Impact of BPA on cardio-pulmonary vascular physiology	1 year	1a) Changes in right cardiac function (RV EF %)

Secondary

Measure	Time frame	Description
Impact of BPA on cardio-pulmonary vascular physiology	1 year	1a) Change in LV tissue composition - T1 (ms)

Countries

Germany

Contacts

Primary ContactSören Jan Backhaus, MD

soeren.backhaus@outlook.de06032-996-2620

Backup ContactAndreas Rolf, MD

a.rolf@kerckhoff-klinik.de06032-996-2620

Outcome results