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Clinical Trials/NL-OMON34705
NL-OMON34705
Completed
N/A

Cardiac sympathetic innervation imaging in patients with trastuzumab induced cardiotoxicity - CARIT

eids Universitair Medisch Centrum0 sites30 target enrollmentTBD

Overview

Phase
N/A
Intervention
Not specified
Conditions
Trastuzumab induced cardiotoxicity
Sponsor
eids Universitair Medisch Centrum
Enrollment
30
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Observational non invasive

Investigators

Eligibility Criteria

Inclusion Criteria

  • Adult patients with confirmed HER\-2 positive breast cancer (immunohistochemistry score 3 or fluorescence in\-situ hybridization positive) who have completed local regional therapy and treatment with trastuzumab or are still on treatment with trastuzumab.
  • Permanent LVEF \<\=50% after treatment with trastuzumab, and/or
  • A permanent relative decrease of \>\=10% from baseline measured by means of echocardiography or MUGA scan and confirmed after 3 weeks after/during treatment with trastuzumab, and/or
  • Symptomatic congestive heart failure defined as NYHA class III/IV
  • Age 18\-80 years.
  • Signed informed consent
  • Amendement: Add control group: patients without a permanent relative decrease of \>\=10% from baseline measured by means of echocardiography or MUGA scan and confirmed after 3 weeks after/during treatment with trastuzumab, and/or symptomatic congestive heart failure defined as NYHA class III/IV

Exclusion Criteria

  • Pre\-existing cardiac disease such as heart failure, ischemic and valvular heart disease, arrhythmia or poorly controlled hypertension.
  • Concomitant inflammatory disease.
  • Pregnancy/beast feeding.
  • Allergy against radiopharmaceutical (99m Tc\-based tracer) for MUGA scan.

Outcomes

Primary Outcomes

Not specified

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