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RecruitingNCT06073509WATCHUpdated Nov 8, 2023

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

An observational study in Breast Cancer, Radiation Toxicity and Atrial Fibrillation, sponsored by Sophie JACOB. Recruiting at 1 site in France. Open to female participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2023-11-08.

Sponsored by Sophie JACOB · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year ago, but the record still lists the study as recruiting.
  • Started Oct 2023; still recruiting 3 years later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
200
Ages
65 Years and older
Sex
Female
01

Study 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.
02

Conditions studied

  • Breast Cancer
  • Radiation Toxicity
  • Atrial Fibrillation
  • Cardiac Arrhythmia
  • Cardiac Disease
03

In context

Breast Neoplasms

14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.

This study's planned enrollment of 200 is close to the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Sophie JACOB is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients treated with RT for breast cancer 5 years ago who come at radiotherapy service Clinique Pasteur for their last visit as part of the regular follow-up of patients by the radiation oncologist for 5 years.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Women treated surgically for primary cancer of the left or right breast and for whom 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Breast cancer patients treated with RT 5 years ago

    Retrospective and cross-sectional data collection based on a medical questionnaire and screening for atrial fibrillation and other cardiac arrhythmias and diseases.

    Diagnostic Test: Screening for atrial fibrillation and other cardiac arrhythmias and diseases

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, ...)

06

What researchers measure

Primary outcomes

  1. Incidence of AF

    AF previously diagnosed between RT and RT+5 years or silent AF incidentally diagnosed at 5-year post-RT screening

    Time frame: 5 years

Secondary outcomes

  1. Incidence of non AF cardiac arrhythmia

    non AF arrhythmia previously diagnosed between RT and RT+5 years and/or incidentally diagnosed at 5-year post-RT screening

    Time frame: 5 years

  2. Incidence of other cardiac diseases

    other cardiac diseases previously diagnosed between RT and RT+5 years and/or incidentally diagnosed at 5-year post-RT

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
  • Clinique Pasteur
    Toulouse, France
    Recruiting
    • Gaëlle Jimenez, MD · Contact
    • Serge Boveda, MD, PhD · Principal investigator
    • Baptiste Pinel, MD · Sub investigator
    • Loic Panh, MD · Sub investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2023 (actual). Primary completion is estimated for Oct 2025, 23 months after the start.

Of 1,191 non-industry observational studies under Breast Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 139. This study's planned 23 months is below that.

Counting every sponsor, half of 1,380 studies reached it within 55 months; a quarter within 25 and three quarters within 126.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 4, 2023
First posted
Oct 10, 2023
StartActual
Oct 25, 2023
Primary completionEst.
Oct 20, 2025
CompletionEst.
Nov 20, 2025
Last update
Nov 8, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06073509
Lead sponsor
Sophie JACOB
Collaborators
Clinique Pasteur Toulouse, Centre Francois Baclesse, Institut Curie
Responsible party
Sophie JACOB (Study Coordinator, Institut de Radioprotection et de Surete Nucleaire) — Sponsor-investigator
First posted
Oct 10, 2023
Start date
Oct 25, 2023
Primary completion
Oct 20, 2025 (estimated)
Completion
Nov 20, 2025 (estimated)
Last update
Nov 8, 2023

Study contacts

Sophie Jacob, PhD
Contact
sophie.jacob@irsn.fr
+33561145608
Sophie Jacob, PhD
study chair · Institut de Radioprotection et de Surete Nucleaire

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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