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Losartan in Prevention of Radiation-Induced Heart Failure

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05607017
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
11
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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)

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Role of Losartan in the Prevention of Early Structural Changes Associated With Radiation-Induced Heart Failure
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Radiation Therapy and Losartan

Participants will receive radiation therapy 5x weekly over 1-6 weeks. Participants will receive Losartan 1x daily during radiation therapy and for up to 6 months afterward then be followed for 1 year

Drug: Losartan
Taken Orally
Other Names:
  • Losartan Potassium

    • Radiation: Radiation Therapy
    Photon Radiation Therapy

    Outcome Measures

    Primary Outcome Measures

    1. Extracellular Volume (ECV) of Myocardial Fibrosis [6 months]

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

    Secondary Outcome Measures

    1. Serum cardiac biomarker [6 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Cancer Center Boston Massachusetts United States 02114

    Sponsors and Collaborators

    • Massachusetts General Hospital

    Investigators

    • Principal Investigator: Rachel Jimenez, MD, Massachusetts General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rachel Beth Jimenez, Principal Investigator, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT05607017
    Other Study ID Numbers:
    • 22-457
    First Posted:
    Nov 7, 2022
    Last Update Posted:
    Nov 7, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Rachel Beth Jimenez, Principal Investigator, Massachusetts General Hospital
    Breast Cancer
    Myocardial Fibrosis
    Radiation-Induced Fibrosis
    Additional relevant MeSH terms:
    Heart Failure
    Fibrosis
    Losartan

    Study Results

    No Results Posted as of Nov 7, 2022