Status:
UNKNOWN
Cardiac Impairments Following Pediatric Cardiotoxic Anti-cancer Treatment
Lead Sponsor:
Technical University of Munich
Collaborating Sponsors:
Ludwig-Maximilians - University of Munich
Conditions:
Cardiovascular Diseases
Pediatric Cancer
Eligibility:
All Genders
10-25 years
Brief Summary
This study aims at investigating the feasibility of recruitment and application of a method regarding early detection of subclinical changes in cardiac health after completion of acute cancer treatmen...
Detailed Description
Cardiovascular late effects following treatment for pediatric cancer are problematic. Early detection of subclinical changes is hardly possible using conventional diagnostic methods, but seems to be f...
Eligibility Criteria
Inclusion
- Inclusion criteria for all participants:
- Aged between 10 and 25 years
- Body height of ≥1,40m (required for performing the examination on the semi supine bicycle ergometer)
- Signed informed assent (minor participant) and consent (legal guardian and full-aged participant)
- Additional inclusion criteria for participants following cancer treatment:
- Completion of acute cancer treatment with anthracyclines and/or chest radiation
- End of treatment 12 months and five years ago (± three months)
- Medical approval for study participation
- Additional inclusion criteria for healthy control subjects:
- \- Appropriate as matched pair with respect to age and gender
- Exclusion Criteria:
- Known cardiovascular diseases (incoherent with cardiotoxic treatment)
- Inability to follow study instructions (e.g., mental retardation, language)
- Acute orthopedic injury (e.g., bone fracture) or orthopedic impairments that preclude examination on a bicycle ergometer (e.g., instable prosthetic device)
- All participants receive a basic physical and cardiological examination at rest as part of the study protocol to ensure capability before performing the exercise stress echocardiography.
Exclusion
Key Trial Info
Start Date :
February 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05261256
Start Date
February 1 2022
End Date
December 31 2024
Last Update
December 5 2023
Active Locations (1)
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1
Institute of Preventive Pediatrics, Department of Sport and Health Sciences, Technical University of Munich, Germany
Munich, Germany, 80992