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Atrial Fibrillation and Other Cardiac Arrhythmias and Diseases After Radiotherapy for Breast Cancer : Watch Your HeaRT

Watch Your HeaRT Study - Screening and Risk Analysis of Atrial Fibrillation and Other Cardiac Arrhythmias and Diseases After Radiotherapy for Breast Cancer

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06073509
Acronym
WATCH
Enrollment
200
Registered
2023-10-10
Start date
2023-10-25
Completion date
2025-11-20
Last updated
2023-11-08

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

Conditions

Atrial Fibrillation, Breast Cancer, Cardiac Arrhythmia, Cardiac Disease, Radiation Toxicity

Brief summary

The goal of this interventional study is to evaluate the risk of atrial fibrillation (AF) and other cardiac arrhythmias and diseases in breast cancer patients treated with radiation therapy (RT). In addition to regular follow-up of patients by the radiation oncologist for 5 years, cardiovascular screening at the end of follow-up, combining the use of a connected watch and a cardiological check-up, could make it possible to identify precisely the types and frequencies of these sometimes asymptomatic, and probably underestimated, cardiac diseases. The main questions it aims to answer are: * To assess the incidence of AF and other cardiac arrhythmias and diseases occurring within 5 years after RT * To evaluate absorbed doses in the heart and cardiac substructures (chambers, conduction nodes, coronaries, pulmonary veins) based on auto-segmentation models developped with deep learning algorithms * To investigate whether the risk of AF and other cardiac arrhythmias and diseases is associated with cardiac irradiation characterized by these absorbed doses (dose-response relationship) Participants will be included between 2023 and 2025, 5 years after their RT: * Retrospective data collection will be based on a medical questionnaire designed to identify cardiac pathologies present prior to RT and those having occured in the past, between RT and 5 years post-RT. * Cross-sectional data collection will be based on screening for cardiac pathologies using a connected watch worn for 1 month (silent AF screening) and a cardiology consultation (including ECG and echocardiography) to identify cardiac pathologies at 5 years post-RT possibly not identified in the retrospective data collection.

Interventions

DIAGNOSTIC_TESTScreening for atrial fibrillation and other cardiac arrhythmias and diseases

In addition to retrospective data collection based on a medical questionnaire, a 5-year post-RT cardiovascular screening will include: * connected smartwatches for atrial fibrillation screening * complete ECG for other cardiac arrhythmias * echocardiography for other cardiac diseases (including cardiac dysfunction, cardiomyopathy, valvulopathy, ...)

Sponsors

Clinique Pasteur Toulouse
CollaboratorOTHER
Centre Francois Baclesse
CollaboratorOTHER
Institut Curie
CollaboratorOTHER
Sophie JACOB
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Women treated surgically for primary cancer of the left or right breast and for whom adjuvant treatment is RT with irradiation of the breast or chest wall and possibly irradiation of lymph node chains, * Adjuvant radiotherapy performed at Clinique Pasteur between 2018 and 2020, * 5-year post-RT follow-up radiation oncologist consultation performed at Clinique Pasteur * Age ≥ 65 years at the time of the 5-year post-RT follow-up consultation * Own a smartphone and able to understand and use digital tools alone and/or with the help of a caregiver ; * Patient having consented to connected follow-up, * Be affiliated to a social security scheme or equivalent * Be willing to participate in the study and have signed the consent form

Exclusion criteria

* History of cancer before breast cancer RT * Recurrence of breast cancer or other cancer treated after breast cancer RT * History of atrial fibrillation prior to breast cancer RT

Design outcomes

Primary

MeasureTime frameDescription
Incidence of AF5 yearsAF previously diagnosed between RT and RT+5 years or silent AF incidentally diagnosed at 5-year post-RT screening

Secondary

MeasureTime frameDescription
Incidence of non AF cardiac arrhythmia5 yearsnon AF arrhythmia previously diagnosed between RT and RT+5 years and/or incidentally diagnosed at 5-year post-RT screening
Incidence of other cardiac diseases5 yearsother cardiac diseases previously diagnosed between RT and RT+5 years and/or incidentally diagnosed at 5-year post-RT

Countries

France

Contacts

Primary ContactSophie Jacob, PhD
sophie.jacob@irsn.fr+33561145608

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026