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

• Sponsor: Heinrich-Heine University, Duesseldorf (Other)
• Overall Status: Completed
• CT.gov ID: NCT03940625
• Collaborator: (none)
• Enrollment: 69
• Location: 1
• Actual Duration (Months): 82.9
• Patients Per Site Per Month: 0.8

Study Details

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	Intervention/Treatment	Phase
Breast Cancer; Myocardial Damage; Cardiotoxicity	Diagnostic Test: Cardiac MRI and echocardiography, laboratory parameters	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
• Actual Enrollment: 69 participants
• Allocation: N/A
• 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: Jun 3, 2015
• Actual Primary Completion Date: Apr 30, 2022
• Actual Study Completion Date: Apr 30, 2022

Outcome Measures

Primary Outcome Measures

1. 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

1. reduction of the left ventricular global longitudinal strain (GLS) by over 15% [after 12 months]

   determination of GLS via strain analysis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Division of Cardiology, Pulmonary Disease and Vascular Medicine	Dusseldorf		Germany	40225

Sponsors and Collaborators

• Heinrich-Heine University, Duesseldorf

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Heinrich-Heine University, Duesseldorf
• ClinicalTrials.gov Identifier: NCT03940625
• Other Study ID Numbers: 15-002
• First Posted: May 7, 2019
• Last Update Posted: May 25, 2022
• Last Verified: May 1, 2022

• 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: breast cancer; antracyclines; cardiotoxity; myocardial damage; MRI; T2 mapping; diastolic function; echocardiography; early detection; strain analysis
• Additional relevant MeSH terms: Cardiotoxicity

Study Results

No Results Posted as of May 25, 2022