NCT05607017

Losartan in Prevention of Radiation-Induced Heart Failure

The Role of Losartan in the Prevention of Early Structural Changes Associated With Radiation-Induced Heart Failure

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to see if losartan affects the chances of developing radiation-induced heart failure in patients who are receiving radiation therapy as part of standard of care treatment for breast cancer. The interventions involved in this study are: * Losartan * Radiation Therapy (standard of care)

Detailed description

This is a pilot study examining whether losartan prevents radiation therapy-induced myocardial fibrosis (thickening of the heart tissue), which can cause heart failure, in breast cancer patients receiving radiation therapy. Losartan is an U.S. Food and Drug Administration (FDA) approved drug used to treat hypertension (high blood pressure) and heart failure. The U.S. Food and Drug Administration (FDA) has not approved losartan for use in the treatment of breast cancer. The FDA has approved radiation therapy as a treatment option for breast cancer. The research study procedures include: screening for eligibility and study treatment including evaluations and follow up visits. It is expected participants will be on the study for 1 year. It is expected that about 10 people will take part in this research study.

Conditions

• Breast Cancer
• Myocardial Fibrosis
• Radiation-Induced Fibrosis

Interventions

Type	Name	Description
DRUG	Losartan	Taken Orally
RADIATION	Radiation Therapy	Photon Radiation Therapy

Timeline

• Start date: 2023-09-13
• Primary completion: 2025-10-07
• Completion: 2025-10-07
• First posted: 2022-11-07
• Last updated: 2026-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study