Trials / Completed
CompletedNCT03940625
Anthracycline Induced Cardiotoxicity - Early Detection by Combination of Diastolic Strain and T2-mapping
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 69 (actual)
- Sponsor
- Heinrich-Heine University, Duesseldorf · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
In order to answer the question, patients with breast cancer, who will undergo a chemotherapeutic treatment with antracycline, will be examined before chemotherapy (including cmr and echocardiography) and after chemotherapy at different times within one year.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Cardiac MRI and echocardiography, laboratory parameters | 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) |
Timeline
- Start date
- 2015-06-03
- Primary completion
- 2022-04-30
- Completion
- 2022-04-30
- First posted
- 2019-05-07
- Last updated
- 2022-05-25
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT03940625. Inclusion in this directory is not an endorsement.