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

Recruiting

• Conditions: Atrial Fibrillation; Breast Cancer; Cardiac Arrhythmia; Cardiac Disease; Radiation Toxicity
• Interventions: Diagnostic Test: Screening for atrial fibrillation and other cardiac arrhythmias and diseases

• Registration Number: NCT06073509
• Lead Sponsor: Sophie JACOB

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-04
• Study First Submitted QC: 2023-10-04
• Study First Posted: 2023-10-10
• Study Start: 2023-10-25
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-06
• Last Update Posted: 2023-11-08
• Primary Completion: 2025-10-20
• Study Completion: 2025-11-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast cancer patients treated with RT 5 years ago	Screening for atrial fibrillation and other cardiac arrhythmias and diseases	Retrospective and cross-sectional data collection based on a medical questionnaire and screening for atrial fibrillation and other cardiac arrhythmias and diseases.

Primary Outcome Measures

Name	Time	Method
Incidence of AF	5 years	AF previously diagnosed between RT and RT+5 years or silent AF incidentally diagnosed at 5-year post-RT screening

Secondary Outcome Measures

Name	Time	Method
Incidence of non AF cardiac arrhythmia	5 years	non AF arrhythmia previously diagnosed between RT and RT+5 years and/or incidentally diagnosed at 5-year post-RT screening
Incidence of other cardiac diseases	5 years	other cardiac diseases previously diagnosed between RT and RT+5 years and/or incidentally diagnosed at 5-year post-RT

Trial Locations

Locations (1)

Clinique Pasteur; 🇫🇷 Toulouse, France