drugset / Trial / NCT03186404

Statins for the Primary Prevention of Heart Failure in Patients Receiving Anthracycline Pilot Study

NCT03186404

RandomizedParallel-groupQuadruple-blindPrevention

Summary

Anthracycline (AC) chemotherapy has substantially reduced the mortality rate from several common cancers globally. Unfortunately, AC treatment is associated with up to 19% risk of heart failure (HF). Current standard of care for preventing AC induced HF (AIHF) is cardiac surveillance followed by initiation of treatment once HF is diagnosed. With this approach 89% of patients fail to recover heart function and 46% will experience adverse cardiac events. Therefore there is a need for effective preventive therapy to reduce the risk of AIHF. Based on small human studies, animal studies, and our own pilot data, statins are an ideal class of drug for this purpose. We will conduct a pilot double blinded, placebo controlled, randomized controlled trial to assess whether pre-treatment with statins before AC can prevent heart dysfunction. Eligible patients with cardiovascular risk factors scheduled to receive AC will be recruited. They will be randomized to statin therapy or placebo and followed until the end of cancer treatment. Primary outcome is the difference in cardiac MRI-determined left ventricular ejection fraction between pre-AC and end of treatment.

Timeline

Start
2018-05-10
Primary completion
2021-12-21
Completion
2023-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule 40 mg