Complications, risks and diagnostic significance of endomyocardial biopsies for the diagnosis of cardiomyopathies in children and adolescents

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00039056

Enrollment

400

Registered

2026-02-03

Start date

2025-03-21

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

I42 I40 I33 T86 D86 E85

Interventions

Group 1: Retrospective analysis of all patients who underwent an endomyocardial biopsy between 2015 and 2025. For this purpose, patient age, height and weight, indication, complications during sample

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Data Analysis of patients who underwent endomyocardial biopsy from 2015 to 2025

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the study is the complication rate of endomyocardial biopsies in pediatric patients, assessed during the procedure (T0) and immediately post-interventionally (T1). Retrospective data collection is conducted from medical records using standardized complication documentation, distinguishing between major complications such as cardiac tamponade, life-threatening arrhythmias, and death, as well as minor complications such as pericardial effusion without tamponade and transient arrhythmias.	—

Measure

Time frame

The primary endpoint of the study is the complication rate of endomyocardial biopsies in pediatric patients, assessed during the procedure (T0) and immediately post-interventionally (T1). Retrospective data collection is conducted from medical records using standardized complication documentation, distinguishing between major complications such as cardiac tamponade, life-threatening arrhythmias, and death, as well as minor complications such as pericardial effusion without tamponade and transient arrhythmias.

—

Secondary

Measure	Time frame
- Diagnostic yield of endomyocardial biopsies (histopathological findings) - Specific risk factors for complications in different age groups - Long-term consequences and clinical outcome of patients - Correlation between biopsy results, clinical diagnosis and therapy	—

Countries

Germany

Contacts

Public ContactNikolaus Haas

LMU Klinikum der Universität München, Abteilung für Kinderkardiologie und Pädiatrische Intensivmedizin

Nikolaus.Haas@med.uni-muenchen.de+49 (0) 89-4400-73941

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026