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NCT Number: NCT07299227

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

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.

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Key information

Conditions

CTEPH

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kerckhoff-Klinik

Bad Nauheim, Hesse, 61231, Germany

Location status: Recruiting

Location contact

Markus Schönburg, MD

CONTACT

[email protected]

06032-996-2620

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Impact of BPA on cardio-pulmonary vascular physiology

    Time frame: 1 year

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

  2. Impact of BPA on cardio-pulmonary vascular physiology

    Time frame: 1 year

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

  3. Impact of BPA on cardio-pulmonary vascular physiology

    Time frame: 1 year

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

  4. Impact of BPA on cardio-pulmonary vascular physiology

    Time frame: 1 year

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

  5. Impact of BPA on cardio-pulmonary vascular physiology

    Time frame: 1 year

    2c) Changes in pulmonary artery flow (pulse wave velocity m/s)

Secondary outcomes

  1. Impact of BPA on cardio-pulmonary vascular physiology

    Time frame: 1 year

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

  2. Impact of BPA on cardio-pulmonary vascular physiology

    Time frame: 1 year

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

  3. Impact of BPA on cardio-pulmonary vascular physiology

    Time frame: 1 year

    • Change in RA phasic function (%).

Study contacts

Contact information is provided by the study sponsor or research team.

Andreas Rolf, MD

CONTACT

[email protected]

06032-996-2620

Sören Jan Backhaus, MD

CONTACT

[email protected]

06032-996-2620

Sponsors and collaborators

Lead sponsor

Kerckhoff Klinik

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 23, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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