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

NCT ID: NCT03940625

Last Updated: 2022-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-03
• Study Completion Date: 2022-04-30

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.

Conditions

Breast Cancer; Myocardial Damage; Cardiotoxicity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

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)

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 39014463 (View on PubMed)

Other Identifiers

15-002

Identifier Type: -

Identifier Source: org_study_id