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Functional and structural analysis of the microcirculation and endothelial glycocalyx, as well as Proteomicsanalysis on patients with congenital heart defects especially with univentricular heart and Fontan-palliation

Functional and structural analysis of the microcirculation and endothelial glycocalyx, as well as Proteomicsanalysis on patients with congenital heart defects especially with univentricular heart and Fontan-palliation

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00035631
Enrollment
90
Registered
2024-12-17
Start date
2024-04-15
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Q23.4

Interventions

Group 1: Children und Adults with univentrikular heart and Fontan-palliation Group 2: Patients with other congenital heart defects Group 3: Children and adults without congenital heart defects

Sponsors

Klinikum der Universität München
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patient group: Patients with the following criteria should be included in the study: - Patients with a univentricular heart and completed palliation according to the Fontan principle - There is no age limit, palliation according to the Fontan principle is usually completed from the age of two, but earlier or much later completion of Fontan palliation is also possible. Since children with Fontan circulation reach adulthood, adult subjects will also be included in the study. Control group: - Patients with other congenital heart defects who are matched to the study group in terms of gender and age. - Healthy patients, siblings if possible, or patients who are matched to the study group in terms of gender and age.

Exclusion criteria

Exclusion criteria: General: Lack of consent to participate in the study or withdrawal of consent - All subjects must be free of infection during the examination, as an infection has a proven effect on microcirculation. - For healthy control patients: They must not have any underlying cardiovascular disease, including all diseases that affect the cardiovascular system, e.g. diabetes mellitus, underlying oncological disease with a history of chemotherapy and neuromuscular diseases

Design outcomes

Primary

MeasureTime frame
By means of structural and functional examination, especially of the vascular endothelium, the detection of corresponding changes should contribute to the general understanding of the changes in Fontan palliation.

Secondary

MeasureTime frame
Is there a connection between the above-mentioned measured values ??(point 1) and/or corresponding changes over time (point 2) and Fontan-specific clinical parameters (e.g. presence of a failing Fontan, hypoalbuminemia, Fontan-specific hemodynamic parameters)

Countries

Germany

Contacts

Public ContactAndré Jakob

Klinikum der Universität München

Andre.Jakob@med.uni-muenchen.de+49 89 4400 72494

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jul 23, 2026