The aim of our study is to assess the prevalence of cardiac dysfunction and undiagnosed heart failure in women registered in general practice with a history of breast cancer who received chemotherapy and / or radiotherapy as compared to a matched…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Haematopoietic neoplasms (excl leukaemias and lymphomas)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of this study is the proportion of women with a systolic
and / or diastolic cardiac dysfunction at echocardiography.
Secondary outcome
The secondary outcome is heart failure: a combination of clinical complaints
and objective abnormalities at physical examination, laboratory examination or
echocardiography.
Background summary
It is important to assess whether there are women with yet unknown cardiac
dysfunction or heart failure as early diagnosis provides the opportunity for
early treatment thus preventing deterioration of cardiac function and improving
the prognosis of patients. To get a reliable estimate of the prevalence of
these problems it is important to get data from an unselected population.
Study objective
The aim of our study is to assess the prevalence of cardiac dysfunction and
undiagnosed heart failure in women registered in general practice with a
history of breast cancer who received chemotherapy and / or radiotherapy as
compared to a matched female control population.
Study design
The method of this study is a cross-sectional design in which women in general
practice who have been treated for breast cancer with chemo and / or
radiotherapy and an age and general practitioner (GP) matched female control
population will be screened on the presence of cardiac dysfunction and heart
failure.
Study burden and risks
The risks of the study are minimal, as all investigations are non-invasive,
except for the vena puncture.
The burden of the study for the participants comprises of one visit to the GP*s
office to fill in questionnaires and for a limited physical examination (blood
pressure, auscultation of the heart), a visit to the laboratory for blood tests
and electrocardiography, and a visit to the hospital for echocardiography.
The consent form will include a paragraph on incidental findings and the option
to refuse to be informed about any unexpected abnormality. If the patient want
to be informed on (incidental) findings they can fill in on the consent form in
what way this will take place (e.g. via their GP).
A. Deusinglaan 1
Groningen 9713 AV
NL
A. Deusinglaan 1
Groningen 9713 AV
NL
Listed location countries
Age
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)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL42193.042.12 |