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Search / Trial NCT06073509

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

Launched by SOPHIE JACOB · Oct 4, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

The "Watch Your HeaRT" clinical trial is studying the risk of heart problems, specifically a condition called atrial fibrillation (AF), in women who have received radiation therapy for breast cancer. Researchers want to understand how common these heart issues are in the years following treatment and if the amount of radiation the heart receives during therapy affects this risk. They will use a connected watch and heart check-ups to monitor participants' heart health over a five-year period.

To be eligible for this study, women must be at least 65 years old, have undergone surgery for breast cancer, and received radiation therapy between 2018 and 2020. Participants should be able to use a smartphone and agree to a connected follow-up. Those who join the study will have their heart health checked through a questionnaire and a month-long watch monitoring along with a visit to a heart specialist. This trial aims to ensure that any heart issues that may arise after radiation therapy are identified and addressed, helping to improve long-term health outcomes for breast cancer survivors.

Gender

FEMALE

Eligibility criteria

  • 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

About Sophie Jacob

Sophie Jacob is a dedicated clinical trial sponsor committed to advancing medical research through innovative and ethical trial management. With a focus on developing effective treatments across various therapeutic areas, Sophie Jacob collaborates closely with healthcare professionals, regulatory bodies, and research institutions to ensure the highest standards of safety and efficacy in clinical studies. Emphasizing transparency and participant welfare, the organization strives to facilitate breakthroughs that enhance patient care and contribute to the global medical community.

Locations

Toulouse, , France

Patients applied

0 patients applied

Trial Officials

Sophie Jacob, PhD

Study Chair

Institut de Radioprotection et de Surete Nucleaire

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported