Cardiovascular DiseasesNCT05261256
Cardiac Impairments Following Pediatric Cardiotoxic Anti-cancer Treatment
An observational study of Cardiovascular Diseases and Pediatric Cancer, run by Technical University of Munich at 1 site in Germany.
Trial 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 treatment during childhood and adolescence. Read more about this study
- Who is it for?
- Ages 10 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Pediatric Cancer
- What is being tested?
- Exercise stress echocardiography
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2022to 30 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Participants with a history of pediatric cancer will be recruited during appointments in follow-up care at two departments for pediatric cancer in Munich. Healthy peers will be recruited within social environment of participants with a history of cancer (siblings, close friends) and within schools and sport clubs.
Who may be able to join
- 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)
Show all 9Show fewer
- Medical approval for study participation
- Additional inclusion criteria for healthy control subjects:
- Appropriate as matched pair with respect to age and gender
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Preventive Pediatrics, Department of Sport and Health Sciences, Technical University of Munich, Germany
Munich, 80992
About this study
Official title: Early Detection of Cardiac Impairments Following Cardiotoxic Anti-cancer Treatment During Childhood and Adolescence - A Feasibility Study
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 treatment during childhood and adolescence.
Read the 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 feasible during physical strain (exercise stress echocardiography).
This feasibility study examines as main objective the recruitment strategy and investigation method in 10-25-year olds in the first and fifth year after the end of acute anti-cancer therapy (n=40 participants with a history of childhood cancer and n=40 control subjects). The heart function is examined by means of exercise stress echocardiography and spiroergometry in comparison with healthy age- and gender-matched control subjects.
Secondary aims are the evaluation of aditional echocardiography markers and levels of physical activity.
- Conditions
- Cardiovascular Diseases, Pediatric Cancer
- Being tested
- Exercise stress echocardiography
- Keywords
- Childhood cancer, Cardiac impairments, Late effects, Early detection, Prevention, Stress echocardiography
- Medical subject headings
- Cardiovascular Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise stress echocardiographyDiagnostic test
Study participants perform an exercise stress echocardiography on a semi-supine bicycle ergometer using using a continuous incremental bicycle protocol with a work rate increment every 3 minutes according to gender and weight.
| Study group | Role | What they receive |
|---|---|---|
| Participants treated for pediatric cancer | This group includes children, adolescents and young adults treated for pediatric cancer who received anthracyclines and/or chest radiation during treatment. Receives: Diagnostic Test: Exercise stress echocardiography | |
| Healthy control subjects | This group includes healthy children, adolescents and young adults without a history of pediatric cancer as age-and gender-matched control subjects. Receives: Diagnostic Test: Exercise stress echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Criteria 1 - Recruitment Rate
The number of children, adolescents and young adults with a history of pediatric cancer who agree to participate compared to the total number approached for this study.
Measured: Throughout study completion, an average of 2 years
Feasibility Criteria 2 - Acceptance
Number of finished and discontinued exercise stress echocardiographies.
Measured: Throughout study completion, an average of 2 years
Feasibility Criteria 3 - Data Quality
Number of evaluable examination data.
Measured: Throughout study completion, an average of 2 years
Feasibility Criteria 4 - Practicability
Difference between scheduled and required time frame for the single examination.
Measured: Throughout study completion, an average of 2 years
Feasibility Criteria 5 - Participants' Feedback
Feedback questionnaire with multiple choice options and free text answers.
Measured: Throughout study completion, an average of 2 years
Secondary outcomes (9)
Reference Values of Healthy Peers
Assessment of reference values from age- and gender-matched healthy peers (matched pairs).
Measured: Throughout study completion, an average of 2 years
Analysis of Echocardiography Marker 1
Deformation Parameters in % (global longitudinal strain and circumferencial strain)
Measured: During the procedure
Analysis of Echocardiography Marker 2
Ejection Fraction (EF) in %
Measured: During the procedure
Analysis of Echocardiography Marker 3
M-Mode Parameter
Measured: During the procedure
Analysis of Echocardiography Marker 4
Tricuspid Annular Plane Systolic Excursion (TAPSE) in millimeter
Measured: During the procedure
Analysis of Echocardiography Marker 5
Left ventricle end diastolic volume (LVEDV) in ml/m²
Measured: During the procedure
Cardiorespiratory Fitness
Submaximal oxygen uptake VO2peak (ml/kg/min)
Measured: During the procedure
Physical Activity Level post-therapy
For participants with a history of pediatric cancer: Physical activity questionnaire ActiOn post-therapy for the assessment of the amount of moderate-to-vigorous physical activity.
Measured: During the procedure
Physical Activity Level in Healthy Control Subjects
For healthy control subjects: Physical activity questionnaire from the KiGGS study (German Health Interview and Examination Survey for Children and Adolescents).
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 Feb 2022
- Primary completion30 Jun 2025
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich
- Responsible party
- Principal investigator, Sabine Kesting, Technical University of Munich
- Investigators
- Renate Oberhoffer-Fritz, Prof. Dr. med., Study chair, Institute of Preventive Pediatrics, Department of Sport and Health Sciences, TUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05261256
- Sponsor's protocol ID
- German Heart Foundation
- Status last verified
- Aug 2026
- First submitted
- 14 Dec 2021
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Cardiac Impairments Following Cardiotoxic Anti-cancer Treatment During Childhood and Adolescence - A Feasibility Study
- ClinicalTrials.gov ID
- NCT05261256
- Acronym / sponsor ID
- German Heart Foundation
- Conditions
- Cardiovascular Diseases, Pediatric Cancer
- Keywords
- Childhood cancer, Cardiac impairments, Late effects, Early detection, Prevention, Stress echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 treatment during childhood and adolescence.
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 feasible during physical strain (exercise stress echocardiography).
This feasibility study examines as main objective the recruitment strategy and investigation method in 10-25-year olds in the first and fifth year after the end of acute anti-cancer therapy (n=40 participants with a history of childhood cancer and n=40 control subjects). The heart function is examined by means of exercise stress echocardiography and spiroergometry in comparison with healthy age- and gender-matched control subjects.
Secondary aims are the evaluation of aditional echocardiography markers and levels of physical activity.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants treated for pediatric cancer | – | Diagnostic Test: Exercise stress echocardiographyThis group includes children, adolescents and young adults treated for pediatric cancer who received anthracyclines and/or chest radiation during treatment. |
| Healthy control subjects | – | Diagnostic Test: Exercise stress echocardiographyThis group includes healthy children, adolescents and young adults without a history of pediatric cancer as age-and gender-matched control subjects. |
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Participants with a history of pediatric cancer will be recruited during appointments in follow-up care at two departments for pediatric cancer in Munich. Healthy peers will be recruited within social environment of participants with a history of cancer (siblings, close friends) and within schools and sport clubs.
Key inclusion criteria (9 listed)
- 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)
- Completion of acute cancer treatment with anthracyclines and/or chest radiation
- End of treatment 12 months and five years ago (± three months)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise stress echocardiographyStudy participants perform an exercise stress echocardiography on a semi-supine bicycle ergometer using using a continuous incremental bicycle protocol with a work rate increment every 3 minutes according to gender and weight. | Diagnostic test | Healthy control subjects, Participants treated for pediatric cancer |
Primary outcome
Feasibility Criteria 1 - Recruitment Rate
Time frame: Throughout study completion, an average of 2 years
The number of children, adolescents and young adults with a history of pediatric cancer who agree to participate compared to the total number approached for this study.
Feasibility Criteria 2 - Acceptance
Time frame: Throughout study completion, an average of 2 years
Number of finished and discontinued exercise stress echocardiographies.
Feasibility Criteria 3 - Data Quality
Time frame: Throughout study completion, an average of 2 years
Number of evaluable examination data.
Feasibility Criteria 4 - Practicability
Time frame: Throughout study completion, an average of 2 years
Difference between scheduled and required time frame for the single examination.
Feasibility Criteria 5 - Participants' Feedback
Time frame: Throughout study completion, an average of 2 years
Feedback questionnaire with multiple choice options and free text answers.
9 secondary outcomes
Reference Values of Healthy Peers
Time frame: Throughout study completion, an average of 2 years
Analysis of Echocardiography Marker 1
Time frame: During the procedure
Analysis of Echocardiography Marker 2
Time frame: During the procedure
Analysis of Echocardiography Marker 3
Time frame: During the procedure
Analysis of Echocardiography Marker 4
Time frame: During the procedure
Analysis of Echocardiography Marker 5
Time frame: During the procedure
Cardiorespiratory Fitness
Time frame: During the procedure
Physical Activity Level post-therapy
Time frame: During the procedure
Physical Activity Level in Healthy Control Subjects
Time frame: During the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renate Oberhoffer-Fritz, Prof. Dr. med. study chair
Institute of Preventive Pediatrics, Department of Sport and Health Sciences, TUM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Pediatric Cancer, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Criteria 1 - Recruitment Rate (time frame: Throughout study completion, an average of 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.