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

Breast Cancer Clinical Trial

— WATCH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06073509
• Other study ID #: WATCH_2023
• Status: Recruiting
• Start date: October 25, 2023
• Est. completion date: November 20, 2025

Study information

• Verified date: November 2023
• Source: Institut de Radioprotection et de Surete Nucleaire
• Contact: Sophie Jacob, PhD
• Phone: +33561145608
• Email: sophie.jacob[@]irsn.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 20, 2025
• Est. primary completion date: October 20, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation
• Breast Cancer
• Breast Neoplasms
• Cardiac Arrhythmia
• Cardiac Disease
• Heart Diseases
• Radiation Toxicity

Intervention

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, ...)

Locations

Country	Name	City	State
France	Clinique Pasteur	Toulouse

Sponsors (4)

Lead Sponsor	Collaborator
Sophie JACOB	Centre Francois Baclesse, Clinique Pasteur Toulouse, Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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