The aim of the here proposed study (BLOC-II) is to clarify whether cardiac function in survivors of BC should be monitored by GPs. We expect to clarify whether an unselected population of long-term BC survivors is at increased risk of developing…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Left ventricular systolic and diastolic cardiac dysfunction. Systolic cardiac
dysfunction is defined as a LVEF <54%. Diastolic cardiac dysfunction is defined
as e* lateral or e* septal at 2.5% below the normal range for age group.
Secondary outcome
Clinically used LVEF cut-off points <45% and <50%.
- Severe diastolic dysfunction as defined by impaired relaxation in combination
with an increased left atrial volume index (LAVI; defined as >= 34 ml/m2).
- Diagnoses of cardiovascular disease
- Rate of deterioration of cardiac function by change in LVEF
- Global Longitudinal Strain (GLS)
- Biomarkers (e.g. NT-proBNP)
Covariates assessed during new measurement
- Patient characteristics: age, BMI, menopausal state, smoking behavior,
physical activity level,
- Changes in lifestyle
- Symptoms of anxiety, depression and fatigue (HADS & MFI-20)
- Use of cardiovascular medication at time of BLOC-II study
Background variables / predictors (assessed during BLOC-I study)
- Treatment characteristics: administered chemotherapy regimens, cumulative
dosages, antihormone treatments, and radiotherapy site (left or right), RT
dosage on LV cardiac substructures
- Cardiovascular risk factors
- Use of cardiovascular medication
Background summary
In addition to surgery, effective breast cancer (BC) treatment typically
requires chemotherapy, radiotherapy, or both. However, it is still unclear
whether patients with BC are at increased risk of long-term cardiac dysfunction
due to the adverse effects of these therapies. In a cross-sectional study in
primary care, we compared cardiac dysfunction between 350 BC survivors and 350
age- and GP- matched controls without cancer. We found that BC survivors were
at increased risk of mild systolic cardiac dysfunction (left ventricle ejection
fraction: LVEF< 54%). By contrast, there was no significant difference in an
LVEF < 50% or in diastolic dysfunction. To date it remains uncertain whether
the mild or subclinical dysfunction we observed predicts further cardiac
deterioration. Consequently, the translation of these results into guidelines
for the daily practice of the GP is unclear.
Study objective
The aim of the here proposed study (BLOC-II) is to clarify whether cardiac
function in survivors of BC should be monitored by GPs. We expect to clarify
whether an unselected population of long-term BC survivors is at increased risk
of developing cardiac dysfunction, whether in this group at-risk subgroups
exists, and what factors are associated with the highest risk
Study design
We propose a new assessment of cardiac function among women included in the
BLOC-I study. This produces a longitudinal matched cohort design consisting of
two cohorts in primary care.
Study burden and risks
Patients are asked to complete a one-time questionnaire and make a one-time
visit to the hospital for echocardiography and blood sampling. The risk is
negligible.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
In the current BLOC-II study, we will invite all women who previously took part
in the BLOC-I study. Inclusion criteria of that study were: females diagnosed
with stage I-III BC at least five years ago or local or locoregional recurrence
of BC at least five years ago; treatment with chemotherapy and/or radiotherapy.
BC survivors were matched with women of the same age (±1 year) who had the same
GP, but who had no history of cancer or cancer treatment (chemotherapy or
radiotherapy)
Exclusion criteria
Patients unfit to travel to the hospital or fill out questionnaires due to
severe mental or physical illness, based on assessment by their GP, will be
excluded.
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 | NL81110.042.22 |