Statins for the Primary Prevention of Heart Failure in Patients Receiving Anthracycline Pilot Study
Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Dinesh Thavendiranathan University Health Network, Toronto
Collaborators:
Mount Sinai Hospital, Canada Scarborough General Hospital St. Michael's Hospital, Toronto Sunnybrook Health Sciences Centre Unity Health Toronto University Health Network, Toronto