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

NCT07299227 | Recruiting

• 1 other identifier: AZ 158/24
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

CTEPH

Keywords

CTEPH; CMR; 4D flow

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Impact of BPA on cardio-pulmonary vascular physiology

  1 year

• Impact of BPA on cardio-pulmonary vascular physiology

  1 year

• Impact of BPA on cardio-pulmonary vascular physiology

  1 year

Study Arms (1)

CTEPH patient

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All CTEPH patients to undergo BPA

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kerckhoff Klinik: lead

Study Sites (1)

Kerckhoff-Klinik

Bad Nauheim, Hesse, 61231, Germany

RECRUITING

Central Study Contacts

Sören Jan Backhaus, MD

CONTACT

06032-996-2620; soeren.backhaus@outlook.de

Andreas Rolf, MD

CONTACT

06032-996-2620; a.rolf@kerckhoff-klinik.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: December 23, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

DE (1)