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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03940625

Recruitment Status Recruiting

First Posted May 7, 2019

Last update posted August 8, 2019

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.

  • Condition or Disease:Breast Cancer
    Myocardial Damage
    Cardiotoxicity
  • Intervention/Treatment: Diagnostic Test: Cardiac MRI and echocardiography, laboratory parameters
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • Estimated Enrollment: 130 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Diagnostic
  • Official Title: Anthracycline Induced Cardiotoxicity - Early Detection by Combination of Diastolic Strain and T2-mapping
  • Actual Study Start Date: June 2015
  • Estimated Primary Completion Date: December 2022
  • Estimated Study Completion Date: December 2022
Outcome Measures
  • Primary Outcome Measures: 1. reduction of the left ventricular ejection fraction (LV-EF) by 10% to under 50% [ Time Frame: after 12 months ]
    volumetric determination of LV-EF
  • Secondary Outcome Measures: 1. reduction of the left ventricular global longitudinal strain (GLS) by over 15% [ Time Frame: after 12 months ]
    determination of GLS via strain analysis
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: No
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

Contacts and Locations
Contacts

Contact: Florian Bönner, MD ctsu@med.uni-duesseldorf.de

Locations

Germany
Division of Cardiology, Pulmonary Disease and Vascular Medicine
Dusseldorf

Sponsors and Collaborators

Heinrich-Heine University, Duesseldorf

More Information
  • Responsible Party: Heinrich-Heine University, Duesseldorf
  • ClinicalTrials.gov Identifier: NCT03940625 History of Changes
  • Other Study ID Numbers: 15-002
  • First Posted: May 7, 2019 Key Record Dates
  • Last Update Posted: August 8, 2019
  • Last Verified: August 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Heinrich-Heine University, Duesseldorf: myocardial damage
    diastolic function
    echocardiography
    strain analysis
    early detection
    MRI
    antracyclines
    cardiotoxity
    T2 mapping
    breast cancer
  • Additional relevant MeSH terms: Cardiotoxicity