The purpose of this study is to to examine the effects of atorvastatin, a type of statin, on changes to the heart among women undergoing breast cancer treatment. Atorvastatin may reduce or eliminate the harmful effects of chemotherapy treatment to the heart tissue of breast cancer patients.
This is a placebo-controlled study. It will compare the effects of atorvastatin against the effects of a placebo (an inactive substance, such as, a sugar pill) on changes to the heart before and during breast cancer treatment. Participants will be in the study for approximately a year and a half, and the study will enroll up to 60 patients. During that time, there will be six visits that may coincide with standard of care visits. Participants will also receive telephone calls from study staff during the study intervention and a follow-up phase to check-in with them.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
2
Atorvastatin calcium, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.
A substance that has no therapeutic effect, and will be used as a control in testing the study agent.
Cedars-Sinai Medical Center
Los Angeles, California, United States
Change in Global Circumferential Strain (GCS) Measured by Cardiac MRI (CMRI)
Time frame: baseline to 12 months post initiation of statin intervention
Change in Global Longitudinal Strain as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Change in Peak Left Ventricular Twist as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Change in Peak Left Ventricular Torsion as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Change in Left Ventricular Untwisting Rate as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Change in Left Ventricular Ejection Fraction as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Change in Left Ventricular End Diastolic Volume as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Change in Left Ventricular End Systolic Volume as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Change in Cardiac Output as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Change in Left Ventricular Mass as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Change in Left Ventricular Concentricity as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Change in Native T1 as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Change in Post Contrast T1 as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Change in Extracellular Volume as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Change in Native T2 as Measured by CMRI
Time frame: Baseline to 12 months of follow-up