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

NCT ID: NCT07299227

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-01

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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CTEPH

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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CTEPH patient

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kerckhoff Klinik

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kerckhoff-Klinik

Bad Nauheim, Hesse, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Sören Jan Backhaus, MD

Role: CONTACT

06032-996-2620

Andreas Rolf, MD

Role: CONTACT

06032-996-2620

Facility Contacts

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Markus Schönburg, MD

Role: primary

06032-996-2620

Other Identifiers

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AZ 158/24

Identifier Type: -

Identifier Source: org_study_id

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