Anthracycline Induced Cardiotoxicity - Early Detection by Combination of Diastolic Strain and T2-mapping
ANKE
1 other identifier
interventional
69
1 country
1
Brief Summary
Anthracyclines (e.g. Doxorubicin) are an important and highly effective chemotherapeutic. They are used in various tumor entities and are established for breast cancer treatment. The most significant prognostic side effect is cardiotoxicity, which occurs in up to 50 patients. Female gender must be considered an independent risk factor for the incidence and severity of associated heart failure. The aim of this study is to demonstrate that dose-dependent anthracycline-induced cardiotoxicity has a measurable effect on T2 mapping on MRI. The second aim is to demonstrate if the combination of diastolic strain (echo and MRI) and T2 mapping can detect earlier anthracycline-induced myocardial damage than via the established method of the echocardiographic measurement of LV-EF and the conventional quantification of diastolic function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable breast-cancer
Started Jun 2015
Longer than P75 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 3, 2015
CompletedFirst Submitted
Initial submission to the registry
May 6, 2019
CompletedFirst Posted
Study publicly available on registry
May 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2022
CompletedMay 25, 2022
May 1, 2022
6.9 years
May 6, 2019
May 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
reduction of the left ventricular ejection fraction (LV-EF) by 10% to under 50%
volumetric determination of LV-EF
after 12 months
Secondary Outcomes (1)
reduction of the left ventricular global longitudinal strain (GLS) by over 15%
after 12 months
Interventions
Cardiac MRI including cine imaging (volumetric determination of LV-EF), late gadolinium enhancement, strain analysis, T1 mapping and T2 mapping Echocardiography including 3D-EF, diastolic function and strain analysis Determination of laboratory parameters including cardiac enzymes (Troponin T and high sensitivity Troponin T) and cardiac markers (BNP and NT-pro BNP)
Eligibility Criteria
You may qualify if:
- Planned therapy with an anthracycline and at least 1 year follow up
- \>18 years of age
- written informed consent
You may not qualify if:
- prior cardiovascular disease
- diabetes mellitus
- previous therapy with anthracyclines
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, 40225, Germany
Related Publications (1)
Voss F, Nienhaus F, Pietrucha S, Ruckhaberle E, Fehm T, Melz T, Cramer M, Haberkorn SM, Flogel U, Westenfeld R, Scheiber D, Jung C, Kelm M, Polzin A, Bonner F. Anthracycline therapy induces an early decline of cardiac contractility in low-risk patients with breast cancer. Cardiooncology. 2024 Jul 16;10(1):43. doi: 10.1186/s40959-024-00244-y.
PMID: 39014463DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2019
First Posted
May 7, 2019
Study Start
June 3, 2015
Primary Completion
April 30, 2022
Study Completion
April 30, 2022
Last Updated
May 25, 2022
Record last verified: 2022-05