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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Atrial Fibrillation; Radiation Toxicity; Cardiac Arrhythmia; Cardiac Disease
• Intervention / Treatment: Diagnostic test: Screening for atrial fibrillation and other cardiac arrhythmias and diseases

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Sophie Jacob, PhD; Phone Number: +33561145608; Email: sophie.jacob@irsn.fr

Study Locations

• France
  • Toulouse, France
    • Recruiting
    • Clinique Pasteur
    • Contact: Gaëlle Jimenez, MD
    • Principal Investigator: Serge Boveda, MD, PhD
    • Sub-Investigator: Baptiste Pinel, MD
    • Sub-Investigator: Loic Panh, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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, ...)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of AF	AF previously diagnosed between RT and RT+5 years or silent AF incidentally diagnosed at 5-year post-RT screening	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5 years
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	5 years

Collaborators and Investigators

• Sponsor: Sophie JACOB
• Collaborators: Institut Curie; Centre Francois Baclesse; Clinique Pasteur Toulouse
• Investigators: Study Chair: Sophie Jacob, PhD, Institut de Radioprotection et de Surete Nucleaire

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2023
• Primary Completion (Estimated): October 20, 2025
• Study Completion (Estimated): November 20, 2025

Study Registration Dates

• First Submitted: October 4, 2023
• First Submitted That Met QC Criteria: October 4, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Heart Diseases; Breast Neoplasms; Atrial Fibrillation; Arrhythmias, Cardiac
• Other Study ID Numbers: WATCH_2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No