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

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.

Study Overview

• Status: Recruiting
• Conditions: CTEPH

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Andreas Rolf, MD; Phone Number: 06032-996-2620; Email: a.rolf@kerckhoff-klinik.de
• Study Contact Backup: Name: Sören Jan Backhaus, MD; Phone Number: 06032-996-2620; Email: soeren.backhaus@outlook.de

Study Locations

• Germany
  • Hesse
    • Bad Nauheim, Hesse, Germany, 61231
      • Recruiting
      • Kerckhoff-Klinik
      • Contact: Markus Schönburg, MD; Phone Number: 06032-996-2620; Email: m.schoenburg@kerckhoff-klinik.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All CTEPH patients to undergo BPA

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
CTEPH patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of BPA on cardio-pulmonary vascular physiology	1a) Changes in right cardiac function (RV EF %)	1 year
Impact of BPA on cardio-pulmonary vascular physiology	1b) Changes in cardiac function (RV GLS%)	1 year
Impact of BPA on cardio-pulmonary vascular physiology	2a) Changes in pulmonary artery flow (peak flow m/s)	1 year
Impact of BPA on cardio-pulmonary vascular physiology	2b) Changes in pulmonary artery flow (mean flow m/s)	1 year
Impact of BPA on cardio-pulmonary vascular physiology	2c) Changes in pulmonary artery flow (pulse wave velocity m/s)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of BPA on cardio-pulmonary vascular physiology	1a) Change in LV tissue composition - T1 (ms)	1 year
Impact of BPA on cardio-pulmonary vascular physiology	1b) Change in LV tissue composition - ECV (%)	1 year
Impact of BPA on cardio-pulmonary vascular physiology	2) Change in RA phasic function (%).	1 year

Collaborators and Investigators

• Sponsor: Kerckhoff Klinik

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: August 27, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Actual): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: CMR; CTEPH; 4D flow
• Other Study ID Numbers: AZ 158/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No