MedPath

Cardiac dysfunction and undiagnosed heart failure in women as a long term effect of the treatment of breast cancer in an unselected primary care setting

Completed
Conditions
cardiac dysfunction
heart failure
10082206
10018865
Registration Number
NL-OMON39592
Lead Sponsor
niversitair Medisch Centrum Groningen
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
700
Inclusion Criteria

Patients
- Women with breast cancer who were treated with chemotherapy and/or radiotherapy in 2006 or before (minimal follow-up period of five years) and after 1970 (due to old fashion treatment or incomplete data)
- Written informed consent
Controls
- Female patients without a history breast cancer, registered in the general practice of the case-patient, matched on age
- Written informed consent

Exclusion Criteria

Patients and controls
- Patients over 80 years of age at the time of diagnosis (because of an expected high frequency of CVD and a life expectancy of less than 10 years in this age-group)
- Any history of other cancer (possibility of chemotherapy and / or radiotherapy)
- Any history of receiving chemotherapy for other indications
- Women who are unable to participate (e.g. terminally or mentally ill)

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The primary outcome of this study is the proportion of women with a systolic<br /><br>and / or diastolic cardiac dysfunction at echocardiography.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>The secondary outcome is heart failure: a combination of clinical complaints<br /><br>and objective abnormalities at physical examination, laboratory examination or<br /><br>echocardiography.</p><br>
© Copyright 2025. All Rights Reserved by MedPath