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NCT Number: NCT05851053

Breast Cancer Long-term Outcomes on Cardiac Functioning: a Longitudinal Study

Rationale: 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, a comparison on cardiac dysfunction between 350 BC survivors and 350 age- and general practitioner (GP)- matched controls without cancer was made. In that study, 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.

Objective: The aim of the here proposed study is to clarify whether cardiac function in survivors of BC should be monitored by GPs, by assessing 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: 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 population: Survivors of BC, diagnosed ≥11 years ago who received chemotherapy and/or radiotherapy, and a matched reference population with no history of cancer. All participants participated in the Breast cancer Long-term Outcome of Cardiac function (BLOC-I) study.

Main study parameters/endpoints: Left ventricular systolic dysfunction. Systolic cardiac dysfunction is defined as a LVEF <54/50/45%.

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, 9700 AD, Netherlands

Location status: Recruiting

Location contact

Anne PG Crijns, PhD

SUB_INVESTIGATOR

Daan Brandenbarg, PhD

PRINCIPAL_INVESTIGATOR

Geertruida H de Bock, Prof. dr.

PRINCIPAL_INVESTIGATOR

Jourik A Gietema, Prof. dr.

PRINCIPAL_INVESTIGATOR

Laurine T van der Wal, MSc

CONTACT

[email protected]

0031503616154

Laurine T van der Wal, MSc

SUB_INVESTIGATOR

Marjolein Y Berger, Prof. dr.

PRINCIPAL_INVESTIGATOR

Michiel R de Boer, PhD

SUB_INVESTIGATOR

Peter van der Meer, Prof. dr.

PRINCIPAL_INVESTIGATOR

Saskia WMC Maass, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who previously took part in de BLOC-I study will be included. These criteria 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.

Exclusion criteria

  • Patients unfit to travel to the hospital due to severe mental or physical illness, based on assessment by their GP.

Exclusion criteria

for the BC survivors in the BLOC-I study were:

  • metastatic disease at the time of BC diagnosis;
  • BC treatment after 80 years of age;
  • history of treatment for other types of cancer.

Treatment and study plan

Echocardiography

Diagnostic Test

During echocardiography, the following parameters will be assessed:

  • Dimensions
  • Left ventricle function
  • Right ventricle function
  • Valves: Aorta valve and pulmonic valve
  • Other findings such as: frequency, rhythm, quality

Primary outcomes

  1. Left ventricular systolic dysfunction

    Time frame: through study completion (from Ocotober 2022 - December 2024)

    Prevalance of systolic cardiac dysfunction defined as a LVEF <54%

Secondary outcomes

  1. Clinically used LVEF cut-off points <45% and <50%

    Time frame: through study completion (from Ocotober 2022 - December 2024)

    Prevalance of systolic cardiac dysfunction defined as a LVEF <45% and <50%

  2. Course of cardiac function

    Time frame: through study completion (from Ocotober 2022 - December 2024)

    Rate of change of systolic and diastolic cardiac function by change in LVEF

  3. Cardiovascular diseases

    Time frame: through study completion (from Ocotober 2022 - December 2024)

    Prevalence of cardiovascular diseases obtained from electronic patient records

  4. Symptoms of hearth failure

    Time frame: through study completion (from Ocotober 2022 - December 2024)

    Clinical symptoms of heart failure measured using a self-constructed questionnaire

Other outcomes

  1. Patient characteristics

    Time frame: through study completion (from Ocotober 2022 - December 2024)

    age, BMI, menopausal state

  2. Physical activity

    Time frame: through study completion (from Ocotober 2022 - December 2024)

    Changes in Physical Acticity measured with Short Questionnaire to Assess Health-enhancing physical activity (SQUASH)

  3. Depression

    Time frame: through study completion (from Ocotober 2022 - December 2024)

    Symptoms of depression measured with Hospital Anxiety and Depression Scale - Despression (HADS-D)

  4. Anxiety

    Time frame: through study completion (from Ocotober 2022 - December 2024)

    Symptoms of anxiety measured with Hospital Anxiety and Depression Scale - Anxiety (HADS-A)

  5. Fatigue

    Time frame: through study completion (from Ocotober 2022 - December 2024)

    Multidimensional assessment of fatigue mesaured with Multidimensional Fatigue Index - 20 (MFI-20).

  6. Use of cardiovascular medication

    Time frame: through study completion (from Ocotober 2022 - December 2024)

    Use of cardiovascular medication based on electronic patient records

  7. Smoking behavior (self-reported pack years)

    Time frame: through study completion (from Ocotober 2022 - December 2024)

    Smoking behavior

Study contacts

Contact information is provided by the study sponsor or research team.

Daan Brandenbarg, PhD

CONTACT

[email protected]

0031628475305

Laurine T van der Wal, MSc

CONTACT

[email protected]

0031503616154

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Acronym: BLOC-II

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
May 9, 2023
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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