Atorvastatin + Lisinopril for Radiation-Associated Heart Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether atorvastatin (a cholesterol-lowering drug) and lisinopril (a blood pressure medication) can protect the heart from damage caused by radiation therapy for cancers in the chest area. Radiation therapy can lead to heart problems, known as radiation-induced heart disease, which poses a significant concern for cancer survivors. Participants will receive either these medications or a placebo (inactive pill) to determine if the medications help maintain healthy blood flow to the heart. The study seeks individuals undergoing radiation therapy that affects at least 10% of their heart. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.
Will I have to stop taking my current medications?
The trial requires that you do not already use a statin or ACE inhibitor, so if you are currently taking these medications, you would need to stop before participating.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that medications like statins (such as atorvastatin) and ACE inhibitors (like lisinopril) are usually well-tolerated in preventing heart disease. Studies found that people taking atorvastatin had a 13% lower risk of heart-related problems compared to those on a different statin, indicating atorvastatin's general safety.
Atorvastatin and lisinopril are often prescribed for heart issues, having been widely used and studied. They help protect blood vessels and improve heart health. While side effects can occur, these medications are generally safe for most people.
In this trial phase, the main goal is to assess how well patients tolerate the treatment. This typically means earlier studies have already shown it to be somewhat safe. For concerns about side effects or risks, consulting a healthcare professional is advisable.12345Why do researchers think this study treatment might be promising?
Researchers are excited about using atorvastatin and lisinopril for radiation-associated heart disease because these medications tackle the problem from two angles. Unlike conventional treatments that often focus solely on symptoms, atorvastatin helps by lowering cholesterol and reducing inflammation, which can protect the heart tissue from radiation damage. Meanwhile, lisinopril, an angiotensin-converting enzyme (ACE) inhibitor, helps relax blood vessels and lower blood pressure, potentially reducing the strain on the heart. This dual-action approach could offer more comprehensive heart protection for patients undergoing radiation therapy.
What evidence suggests that atorvastatin and lisinopril could be effective for radiation-associated heart disease?
Research has shown that atorvastatin and lisinopril may protect the heart from radiation-induced damage. In this trial, one group of participants will receive statins, such as atorvastatin, and ACE inhibitors, such as lisinopril, to evaluate their combined effect on reducing heart disease risk. Statins can lower the risk of major heart problems and strokes in cancer patients after radiation therapy by reducing inflammation and preventing heart scarring. Lisinopril can help prevent the thickening of heart walls caused by radiation. Together, these medications might reduce the risk of heart disease in patients receiving radiation therapy near the heart.678910
Who Is on the Research Team?
Shivani Sud, MD
Principal Investigator
UNC Lineberger Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with tumors in the chest area (like breast, lung, esophagus, mediastinum, or spine) who are getting radiation therapy that will expose at least 10% of their heart to a moderate dose. Participants must be able to take oral medications and follow study procedures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Radiation Therapy
Participants receive standard radiation therapy with an equivalent dose of at least 25 Gy to at least 10% of the heart
Treatment
Participants receive either placebo or Atorvastatin 20 mg plus Lisinopril 5 mg daily during radiation therapy and continue for 6 months post-treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment, including myocardial perfusion imaging and cardiac biomarker assessments
Long-term Follow-up
Rates of major adverse cardiac events are compared between trial groups at follow-up of 1, 2, and 3 years
What Are the Treatments Tested in This Trial?
Interventions
- Atorvastatin
- Lisinopril
Trial Overview
The study tests whether taking atorvastatin (a cholesterol-lowering drug) plus lisinopril (a blood pressure medicine) during and after radiation can protect the heart compared to a placebo. Patients are randomly assigned to either group.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Patients expected to receive ≥25 Gy equivalent dose in 2 Gy fractions (EQD2) to at least 10% of the heart will be treated with statins and angiotensin-converting enzyme (ACE) inhibitors.
Patients expected to receive ≥25 Gy equivalent dose in 2 Gy fractions (EQD2) to at least 10% of the heart will take inhibitors.
Find a Clinic Near You
Who Is Running the Clinical Trial?
UNC Lineberger Comprehensive Cancer Center
Lead Sponsor
Citations
Study Details | NCT07685938 | Pharmacologic Therapies ...
Preclinical and clinical studies show that statins and angiotensin-converting enzyme (ACE) inhibitors may help reduce radiation-induced heart ...
Statin Therapy Reduces Radiation‐Induced Cardiotoxicity in ...
Despite this lower incidence, statin therapy demonstrated a significant protective effect in both groups, with aHRs indicating a meaningful reduction in MACE ...
Advances in radiation-induced heart disease diagnosis ...
Overall, according to in vivo study results, statins exert cardioprotective effects potentially via anti-inflammatory, combining lisinopril with hydration and ...
Statins and ACE Inhibitors for Radiation-Induced Heart ...
This study aims to evaluate if statins and ACE inhibitors can prevent radiation-induced heart disease in cancer patients, by measuring the difference in ...
5.
uspharmacist.com
uspharmacist.com/article/statins-appear-to-reduce-cvd-events-in-cancer-patients-receiving-radiationStatins Appear to Reduce CVD Events in Cancer Patients ...
“Statin use post radiation therapy was associated with a significant reduction in stroke, with a trend toward significantly reducing ...
Statin Use and Major Adverse Cardiovascular Events Among ...
Results: The study included 1011 patients with ischemic heart disease (IHD), predominantly male (78.2%), with a mean age of 59 ± 10.9 years. Non ...
Legacy in Cardiovascular Risk Factors Control
Fewer cardiovascular deaths were observed (11% less; not significant), as well as non-cardiovascular deaths (15%; reaching significance), in those formerly ...
Strategies for Primary Prevention of Coronary Heart Disease ...
For women at low CHD risk, treat-all with high-dose statins was more likely to cause a statin-related adverse event than to prevent a CHD event.
Cardiovascular Prevention Strategies in Breast Cancer
Clinical trial data on pharmacological therapies (e.g., statins) to mitigate the development of CVD in these patients are limited. A CVD prevention program in ...
Patients Taking Lipitor Had a Significantly Reduced Risk of ...
patients taking Lipitor® (atorvastatin calcium) had a significant 13 percent reduction in the relative risk of experiencing a cardiovascular ...
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