Actively Recruiting
Impact of Balloon Pulmonary Angioplasty in CTEPH on Cardiac and Pulmonary Physiology Assessed by State-of-the-art Cardiovascular Magnetic Resonance 4D Flow Haemodynamics
Led by Kerckhoff Klinik · Updated on 2025-12-23
60
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the impact of Balloon Pulmonary Angioplasty (BPA) on cardiac and pulmonary physiology in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). The study focuses on evaluating changes in cardio-pulmonary vascular physiology using advanced Cardiovascular Magnetic Resonance (CMR) 4D flow haemodynamics. Patients referred for BPA will undergo comprehensive standard diagnostic tests including echocardiography, right heart catheterization (RHC), and coronary artery disease assessments through both invasive and non-invasive methods. Participants will receive BPA typically across 5 to 6 consecutive treatment sessions. CMR imaging will be performed before the first BPA session and again after the last intervention to assess treatment effects. The patient recruitment period is planned to last three years, with the last BPA session for the final patient occurring within this timeframe. During the study, patients will undergo standard diagnostic evaluations and CMR scans to monitor heart and lung function changes. Researchers will measure the impact of BPA on cardio-pulmonary vascular physiology over a one-year period. The study involves follow-up CMR assessments to track physiological changes and support understanding of treatment outcomes in CTEPH patients.
CONDITIONS
Brief Title
Impact of BPA in CTEPH on Cardiac and Pulmonary Physiology Assessed by CMR-derived 4D Flow Haemodynamics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient referred to Balloon Pulmonary Angioplasty (BPA)
- Clinical indication for Cardiovascular Magnetic Resonance (CMR)
- Ability to provide informed consent
- Age between 18 and 99 years
You will not qualify if you...
- Non-compliance with study procedures
- Age under 18 years
- Pregnancy
- Contraindications for CMR such as non-CMR compatible devices
- Chronic kidney disease with eGFR less than 30 ml/min
- Allergies to medications used during CMR
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants undergo cardiovascular magnetic resonance (CMR) assessments to evaluate cardiac and pulmonary physiology before Balloon Pulmonary Angioplasty (BPA).
Assessments at baseline and follow-up visits up to 1 year
Duration - Up to 1 year
Participants are monitored to assess the long-term impact of BPA on cardio-pulmonary vascular physiology.
Periodic assessments over 1 year
Trial Site Locations
Total: 1 location
1
Kerckhoff-Klinik
Bad Nauheim, Hesse, Germany, 61231
Actively Recruiting
Research Team
S
Sören Jan Backhaus, MD
A
Andreas Rolf, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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