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

Primary Purpose

Breast Cancer, Myocardial Damage, Cardiotoxicity

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Cardiac MRI and echocardiography, laboratory parameters
Sponsored by
Heinrich-Heine University, Duesseldorf
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring breast cancer, antracyclines, cardiotoxity, myocardial damage, MRI, T2 mapping, diastolic function, echocardiography, early detection, strain analysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Division of Cardiology, Pulmonary Disease and Vascular Medicine

Outcomes

Primary Outcome Measures

reduction of the left ventricular ejection fraction (LV-EF) by 10% to under 50%
volumetric determination of LV-EF

Secondary Outcome Measures

reduction of the left ventricular global longitudinal strain (GLS) by over 15%
determination of GLS via strain analysis

Full Information

First Posted
May 6, 2019
Last Updated
May 19, 2022
Sponsor
Heinrich-Heine University, Duesseldorf
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1. Study Identification

Unique Protocol Identification Number
NCT03940625
Brief Title
Anthracycline Induced Cardiotoxicity - Early Detection by Combination of Diastolic Strain and T2-mapping
Acronym
ANKE
Official Title
Anthracycline Induced Cardiotoxicity - Early Detection by Combination of Diastolic Strain and T2-mapping
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 3, 2015 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Heinrich-Heine University, Duesseldorf

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Myocardial Damage, Cardiotoxicity
Keywords
breast cancer, antracyclines, cardiotoxity, myocardial damage, MRI, T2 mapping, diastolic function, echocardiography, early detection, strain analysis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Diagnostic Test
Intervention Name(s)
Cardiac MRI and echocardiography, laboratory parameters
Intervention Description
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)
Primary Outcome Measure Information:
Title
reduction of the left ventricular ejection fraction (LV-EF) by 10% to under 50%
Description
volumetric determination of LV-EF
Time Frame
after 12 months
Secondary Outcome Measure Information:
Title
reduction of the left ventricular global longitudinal strain (GLS) by over 15%
Description
determination of GLS via strain analysis
Time Frame
after 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Division of Cardiology, Pulmonary Disease and Vascular Medicine
City
Dusseldorf
ZIP/Postal Code
40225
Country
Germany

12. IPD Sharing Statement

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

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