NCT06073509: WATCH

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

Status unknown Last updated 8 November 2023

What this trial tests

trial testing Screening for atrial fibrillation and other cardiac arrhythmias and diseases in Breast Cancer in 200 participants. Status unknown.

Timeline

25 October 2023

Primary endpoint
20 October 2025

20 November 2025

Quick facts

Lead sponsor	Sophie JACOB
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	200
Start date	25 October 2023
Primary completion	20 October 2025
Estimated completion	20 November 2025
Sites	1 location across France

Drugs / interventions tested

• Screening for atrial fibrillation and other cardiac arrhythmias and diseases

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →
• Radiation Toxicity — all drugs for Radiation Toxicity →
• Atrial Fibrillation — all drugs for Atrial Fibrillation →
• Cardiac Arrhythmia — all drugs for Cardiac Arrhythmia →

Sponsor

Sophie JACOB

Who can join

65 and older, female only, with Breast Cancer or Radiation Toxicity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Radiation-induced cardiac substructure damage and dose constraints: a review.
   Li X, Wu Y, Wang Q, Li B, et al · · 2025 · cited 3× · PMID 40474260 · DOI 10.1186/s13014-025-02668-x
2. Screening and Risk Analysis of Atrial Fibrillation After Radiotherapy for Breast Cancer: Protocol for the Cross-Sectional Cohort Study "Watch Your Heart (WATCH)".
   Saint-Lary L, Pinel B, Panh L, Jimenez G, et al · · 2025 · PMID 40466092 · DOI 10.2196/67875
3. Screening and risk analysis of atrial fibrillation after radiotherapy for breast cancer: Rationale and design for the Watch Your HeaRT cohort study (WATCH)
   Saint-Lary L, Pinel B, Panh L, Jimenez G, et al · · 2024 · DOI 10.21203/rs.3.rs-4807666/v1