Early detection and prediction of cardiotoxicity in breast cancer patients treated with chemotherapy using the high sensitivity troponin T assay.

Completed

• Conditions: 10019280; cardiotoxicity; heart failure; 10006291

• Registration Number: NL-OMON37774
• Lead Sponsor: Maxima Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

-Female breast cancer patients
-Age between 30-60 years
-18-weeks of chemotherapy-treatment, adjuvant or neo-adjuvant
-Chemotherapy may include: (AC) adriamycin/cyclophosphamide, (FEC) fluorouracil/epiribicin/cyclophosphamide, (TAC) taxotere/ adriamycin/cyclophosphamide
-Ejection fraction > 50%

Exclusion Criteria

-Ejection fraction <50%
-previous signs of cardiovascular disease
-kidney dysfunction (eGFR <60 ml/min/1,73m^2).
-previous treatment with anthracyclines

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>Relation between hs-TNT values and cardiac dysfunction (measured by left<br /><br>ventricular ejection fraction with echocardiography) after chemotherapy.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives of this study are to investigate the relation between the<br /><br>change in hs-TNT values and cardiac function after Ctx.<br /><br>1. hs-TNT kinetics during Ctx and relation to cardiac function (% LVEF). (delta<br /><br>change within one Ctx cycle, delta change between Ctx cycles, delta change<br /><br>baseline and final hs-TNT value)<br /><br>2. Detection and prediction of cardiotoxicity (definition: an asymptomatic<br /><br>reduction >10% of the LVEF reaching ,<55%, or a symptomatic reduction >5% of<br /><br>the LVEF reaching <55%) by hs-TNT values (single value or delta changes).</p><br>