Early cardiac damage detection with CMR in women with breast cancer

Withdrawn

• Conditions: cardiac damage related to chemotherapy; Chemotherapy induced cardiomyopathy; 10028593; 10006291

• Registration Number: NL-OMON48400
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 55

Inclusion Criteria

Women diagnosed with primary breast cancer receiving (neo-) adjuvant
chemotherapy
Increased cardiotoxicity risk (intermediate, high, very high risk)
Age * 18 years

Exclusion Criteria

Cancer recurrence
Cancer metastasis
History of myocardial infarction or heart failure

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>A relative reduction in GLS from baseline to 2 weeks (+/- 1 week) after<br /><br>chemotherapy discontinuation.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Changes in circulating cardiac biomarkers (hs-Troponin T and NT-proBNP)<br /><br>compared with baseline, measured every 3 weeks before and after each<br /><br>chemotherapy cycle. The endpoint is a clinically significant increase in each<br /><br>biomarker above the normal value ranges between time points. Quality of Life<br /><br>(PROMs) will be evaluated after 1 and 3 years.</p><br>