Pharmacologic Therapies to Mitigate Radiation- Associated Heart Disease
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 6 months
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "The medications will be taken during radiation therapy and continued for 6 months after treatment."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether atorvastatin and lisinopril can help protect the heart from radiation damage. It is for adults getting radiation that is expected to expose at least 10% of the heart to a set radiation dose. Patients are assigned by chance to take either both medicines or a placebo (no active medicine) during radiation and for 6 months after.
Radiation therapy is an essential treatment for tumors in the chest area, including breast, lung, esophageal, mediastinal cancers, and spine metastases. Although technical advances have reduced treatment-related illness and death, radiation exposure to the heart can still cause substantial rates of radiation-induced heart disease (RIHD) among survivors. For example, about 21% of non-small cell lung cancer patients receiving a mean heart dose of 20 Gy or higher experience major adverse cardiac events (MACE) within 2 years. In breast cancer patients, the risk of MACE increases by about 7% for each additional Gy of mean heart dose. There is currently no established medication strategy to prevent or reduce RIHD. Preclinical and clinical studies show that statins and angiotensin-converting enzyme (ACE) inhibitors may help reduce radiation-induced heart disease (RIHD). Statins and ACE inhibitors are generally well tolerated, available as generic drugs, and commonly used to help prevent cardiovascular disease. They may protect the heart by reducing damage to blood vessel lining (endothelial damage), microvascular dysfunction, atherosclerosis, reduced blood flow (ischemia), and fibrosis (scarring). This study is a prospective, randomized, placebo-controlled phase II hybrid decentralized trial. Patients receiving standard radiation therapy and expected to receive an equivalent dose of at least 25 Gy (EQD2) to at least 10% of the heart will be randomly assigned to receive either: * placebo, or * Atorvastatin 20 mg plus Lisinopril 5 mg daily. The medications will be taken during radiation therapy and continued for 6 months after treatment. The study aims to determine whether the intervention can reduce radiation-related decreases in blood flow to the heart, measured using myocardial perfusion imaging, such as positron emission tomography (PET), which is commonly used to evaluate the risk of coronary heart disease.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older when you agree to join.
- Sign a form agreeing to join and allow the release of personal health information.
- Be willing and able to follow study steps, as judged by the study doctor.
- Agree to repeated blood draws and use of your samples for the study.
Who can't join
- Be pregnant or breastfeeding. Breast milk cannot be saved for later use while taking study treatment.
- Already take a statin (a cholesterol medicine) or an ACE inhibitor (a type of blood pressure medicine).
- Already have low blood pressure.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Written informed consent obtained to participate in the study and HIPAA * authorization for release of personal health information. * Subjects is willing and able to comply with study procedures based on the * judgement of the investigator. * Consent for serial blood draws and consent for use of biological specimens. * Age ≥ 18 years at the time of consent Exclusion Criteria: * Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study). * Pre-existing use of a statin or ACE-inhibitor * Pre-existing hypotension
Study sites (1)
NC
- Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill · Chapel Hill, NC 27599Claire Kowalczyk · Study contact · 984-974-0000 · claire_kowalczyk@med.unc.eduShivani Sud, MD · Principal investigatorMore trials in Chapel Hill