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

Breast Cancer Clinical Trial

— ANKE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03940625
• Other study ID #: 15-002
• Status: Completed
• Phase: N/A
• Start date: June 3, 2015
• Est. completion date: April 30, 2022

Study information

• Verified date: May 2022
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Cardiotoxicity
• Myocardial Damage

Intervention

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)

Locations

Country	Name	City	State
Germany	Division of Cardiology, Pulmonary Disease and Vascular Medicine	Dusseldorf

Sponsors (1)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction of the left ventricular ejection fraction (LV-EF) by 10% to under 50%	volumetric determination of LV-EF	after 12 months
Secondary	reduction of the left ventricular global longitudinal strain (GLS) by over 15%	determination of GLS via strain analysis	after 12 months