Anthracycline Induced Cardiotoxicity - Early Detection by Combination of Diastolic Strain and T2-mapping

Not Applicable

Completed

• Conditions: Breast Cancer; Myocardial Damage; Cardiotoxicity

• Registration Number: NCT03940625
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

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.

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.

Study Timeline

• Study Start: 2015-06-03
• Study First Submitted: 2019-05-06
• Study First Submitted QC: 2019-05-06
• Study First Posted: 2019-05-07
• Primary Completion: 2022-04-30
• Study Completion: 2022-04-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-19
• Last Update Posted: 2022-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 69

Inclusion Criteria

• Planned therapy with an anthracycline and at least 1 year follow up
• >18 years of age
• written informed consent

Exclusion Criteria

• prior cardiovascular disease
• diabetes mellitus
• previous therapy with anthracyclines

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
reduction of the left ventricular ejection fraction (LV-EF) by 10% to under 50%	after 12 months	volumetric determination of LV-EF

Secondary Outcome Measures

Name	Time	Method
reduction of the left ventricular global longitudinal strain (GLS) by over 15%	after 12 months	determination of GLS via strain analysis

Trial Locations

Locations (1)

Division of Cardiology, Pulmonary Disease and Vascular Medicine; 🇩🇪 Dusseldorf, Germany