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OpenTrials
Completed

NCT Number: NCT05607017

Losartan in Prevention of Radiation-Induced Heart Failure

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)

Completed

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

->18 years of age

  • Non-metastatic Breast Cancer patients who are scheduled to receive conventional left breast/chest wall RT inclusive of treatment to the internal mammary lymph nodes (IMNs)
  • Prior chemotherapy is permitted
  • Patients must have Left-sided Breast Cancer
  • Ability to understand and the willingness to sign a written informed consent document
  • No contraindication to MRI

Exclusion criteria

  • Person who is pregnant or breastfeeding.
  • Patient unable to swallow oral medication.
  • Patients receiving any other investigational agent will not be excluded from study eligibility, unless the patient is already enrolled in an interventional study evaluating cardiac toxicity
  • Patients already receiving ACE/ARBs.
  • Patients with a history of allergic reactions to Losartan biosimilars.

Treatment and study plan

Losartan

Drug

Taken Orally

Other names: Losartan Potassium

radiation therapy

Radiation

Photon Radiation Therapy

Primary outcomes

  1. Extracellular Volume (ECV) of Myocardial Fibrosis

    Time frame: 6 months

    The primary endpoint is detectable decrease in extracellular volume as measured by cardiac MRI

Secondary outcomes

  1. Serum cardiac biomarker

    Time frame: 6 months

    The secondary objective of this study is to compare pre- and post-Radiation Therapy changes in serum TGF-β levels

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 7, 2022
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.