HEpatic and CArdiac TOxicity Systems modelling.

Withdrawn

• Conditions: Cardiotoxic cardiomyopathy; heart failure.; 10019280

• Registration Number: NL-OMON40984
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 500

Inclusion Criteria

-Patients who have received trastuzumab, epirubicin, doxorubicin, mitoxantrone, daunorubicin, rituximab, idarubicin or taxane treatment for breast cancer, leukaemia*s or lymphomas.
-Age between 18 and 70 years.

Exclusion Criteria

Known cardiac diseases or cardiac abnormalities in the past.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint: development of cardiotoxicity, defined as the most recent<br /><br>guidelines: a reduction of LVEF >5% to LVEF <55% with symptoms of heart failure<br /><br>or an asymptomatic reduction of LVEF of >10% to a LVEF <55%. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Myocardial injury, hypertension, trombo embolic events (veneous trombo<br /><br>embolism/TIA/CVA), bradycardia and QT prolongation on ECG.<br /><br></p><br>