Clinical Trials Directory

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

TypeNameDescription
DIAGNOSTIC_TESTCardiac MRI and echocardiography, laboratory parametersCardiac 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.