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Breast cancer Long-term Outcomes on Cardiac functioning: a longitudinal study

Breast cancer Long-term Outcomes on Cardiac functioning: a longitudinal study - BLOC-II

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON51722
Enrollment
455
Registered
2022-07-05
Start date
2022-10-05
Completion date
Unknown
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cardiac dysfunction heart failure

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
Left ventricular systolic and diastolic cardiac dysfunction. Systolic cardiac dysfunction is defined as a LVEF

Secondary

MeasureTime frame
Clinically used LVEF cut-off points = 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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: May 16, 2026