STOP-CA (Statins TO Prevent the Cardiotoxicity From Anthracyclines)
- Registration Number
- NCT02943590
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
This research study will test whether atorvastatin, a drug commonly prescribed for reducing cholesterol levels, can protect the heart during chemotherapy with doxorubicin. Atorvastatin is from a family of medications that are commonly called "statins"
- Detailed Description
This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of a drug and determine whether the investigational drug works in treating a specific disease. "Investigational" means that the drug is being studied.
The chemotherapy drug that the participant have been scheduled to be treated with, Doxorubicin, has been associated with the development of heart failure in some patients.
This research study is testing whether Atorvastatin can protect the hearts of patients being treated with Doxorubicin and can reduce cardiac injury and the risk of heart failure. Atorvastatin is not approved by the FDA (the U.S. Food and Drug Administration) for use to reduce the cardiac injury after Doxorubicin. Atorvastatin is approved by the FDA for lowering cholesterol and for reducing the risk of heart attack and stroke. The heart is a muscle that pumps blood and Atorvastatin may protect the heart by preserving cardiac muscle function.
The investigators will test whether atorvastatin protects the heart using a combination of imaging tests on the participants heart, blood tests, and stress testing. The imaging tests will involve an echocardiogram (an echo) and cardiac magnetic resonance (CMR), a type of magnetic resonance imaging (MRI) scan.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- > 18 years of age
- All patients with newly diagnosed NHL and HL
- Scheduled to receive anthracycline-based therapy
- Statin use or Statin use is indicated based on guidelines
- Pregnancy or breastfeeding
- Unable to provide informed consent
- Unexplained persistent elevation of transaminases (>3 times upper limits of normal)
- Concomitant use of cyclosporine
- Renal failure: estimated glomerular filtration <45 mL/min/1.73 m2
- Contraindication to a CMR (metallic object, severe claustrophobia, pacemaker, vascular clip
- LVEF of <50% at baseline
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo will be administered at a pre determined dose The drug is taken by mouth, once a day (evening) Atorvastatin Atorvastatin Atorvastatin will be administered at a pre determined dose The drug is taken by mouth, once a day (evening)
- Primary Outcome Measures
Name Time Method The Percentage of Individuals in Each Group With a Significant Decline in the LVEF. 12 months To determine if the administration of statins is associated with a lower percentage of individuals who experience a significant decline in the LVEF at 12 months. The primary outcome was the percentage of participants with an absolute decline in left ventricular ejection fraction (LVEF) of\>10% from prior to chemotherapy to a final value of \<55% over 12 months.
- Secondary Outcome Measures
Name Time Method The Percentage of Participants in Each Group With New Onset Heart Failure. 2 years To determine whether statins reduce the percentage of participants in each group with new onset heart failure after anthracyclines.
Myocardial Extracellular Volume by Cardiac MRI. 1 Year The myocardial extracellular volume (ECV) is the proportion of the myocardium that is estimated to be of extracellular space. Myocardium consists of intracellular space and extracellular space. This measure is an imaging estimate of the extracellular space. The extracellular space can be expanded in diseases where myocardial fibrosis is increased. Thus, this measure is often used as an estimate for the proportion of fibrosis in the heart. It can be expressed as a percentage. Here, based on published literature, we used a cut off of a 3% increase in the ECV from baseline to follow-up as a meaningful increase and compared the propositions of persons with that 3% increase in each group. We are comparing the proportion of persons in each group with a 3% or greater increase in the ECV.
Global Longitudinal Strain (GLS) 1 year GLS is a sensitive measure of cardiac systolic function. Anthracyclines can be associated with impaired global longitudinal strain (GLS). Whether atorvastatin protects against a decline in LV GLS is unknown. GLS is expressed as a percentage. A ≥15% relative decrease in LV GLS was used as a cut off for a significant decrease in GLS based on published data. The Proportions of participants with a relative reduction of ≥15% in LV GLS were evaluated in each group.
Trial Locations
- Locations (4)
Massachusetts general Hospital
🇺🇸Boston, Massachusetts, United States
University of Pennsylvania Medical System
🇺🇸Philadelphia, Pennsylvania, United States
McGill University Health Center
🇨🇦Toronto, Canada
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States