How balloon pulmonary angioplasty changes heart and lung blood flow measured by 4D CMR in CTEPH
Official 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
Run by Kerckhoff Klinik · NCT07299227 · Data updated 2026-11-12
The team will use 4D CMR scans before and after balloon pulmonary angioplasty to see if the procedure changes blood flow patterns and heart function in people with CTEPH.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Kerckhoff Klinik Academic / other |
| Locations | 1 site (Bad Nauheim, Hesse) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | July 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | December 23, 2025 |
| Trial ID | NCT07299227 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with CTEPH who have been referred for BPA, have a clinical indication for CMR, and can provide informed consent.
✕Probably not a fit
Patients with contraindications to CMR (for example non‑MRI‑compatible implants, severe renal impairment, or contrast allergies), those who are pregnant, under 18, or unable to comply with imaging and follow‑up are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study follows adults with chronic thromboembolic pulmonary hypertension (CTEPH) who are referred for balloon pulmonary angioplasty (BPA) at Kerckhoff‑Klinik. Participants undergo standard diagnostic tests including echocardiography, right heart catheterisation, CT or CMR, and coronary work-up as needed, and receive BPA across about five to six sessions. Cardiac magnetic resonance 4D flow imaging is performed before the first BPA session and again after the final session to quantify changes in pulmonary and cardiac haemodynamics. Recruitment is planned over three years and the protocol does not add investigational treatments beyond routine care.
Why it matters
Potential benefit: If successful, the results could help doctors better understand how BPA improves blood flow and heart function and help refine which patients are most likely to benefit and how to monitor them.
How similar studies have gone: BPA is an established treatment that improves haemodynamics in CTEPH and smaller cohorts have used 4D flow CMR to describe flow changes, but serial 4D flow imaging specifically tied to multi‑session BPA is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
-
Kerckhoff-Klinik
Bad Nauheim, Hesse, Germany Recruiting
Study contacts
- Study coordinator: Sören Jan Backhaus, MD
- Email: soeren.backhaus@outlook.de
- Phone: 06032-996-2620
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.