The Role of Losartan in the Prevention of Early Structural Changes Associated With Radiation-Induced Heart Failure
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Extracellular Volume (ECV) of Myocardial Fibrosis
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •>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
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Losartan (Drug)
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
干预措施: Radiation Therapy (Radiation)
结局指标
主要结局
Extracellular Volume (ECV) of Myocardial Fibrosis
时间窗: 6 months
The primary endpoint is detectable decrease in extracellular volume as measured by cardiac MRI
次要结局
- Serum cardiac biomarker(6 months)
研究者
Rachel Beth Jimenez
Principal Investigator
Massachusetts General Hospital