Prophylactic Lisinopril to Prevent Anthracycline Cardiomyopathy.
Status:
Unknown status
Trial end date:
2020-03-15
Target enrollment:
Participant gender:
Summary
The intent of the study is to show the potential benefits of angiotensin converting enzyme
inhibitors in preventing anthracycline induced cardiotoxicity.
This is a prospective, randomized, blinded and placebo-controlled clinical trial that will
enroll patients who are to be treated with anthracycline chemotherapy (doxorubicin,
epirubicin, idrarubicin, or mitoxantone) to either lisinopril or placebo group. The study
will be performed at the Genesys Hurley Cancer Institute. The treating oncologist who intends
to start the patient on anthracycline chemotherapeutic agent will provide the patient with a
recruitment flyer and informed consent form and then referred to the research nurse. Subjects
interested in participation, that do not meet any of the exclusion criteria, will be
consented and enrolled by the research nurse prior to their first treatment with
chemotherapy. Over a period of 1 to 3 weeks the study medication will be titrated in a
stepwise fashion to a target of 20 mg daily, maintaining a systolic blood pressure greater
than 90 mmHg. A baseline echocardiogram with strain and strain rate imaging will be obtained
prior to initiation of anthracycline chemotherapy. Subsequent echocardiograms with strain and
strain rate imaging will be performed every 3 months for a total of 12 months.
Patients will be followed for a total of 12 months, starting on the day of enrollment. We
intend to recruit a total of 200 patients.
The primary endpoint of this study is a change in change in strain and strain rate parameters
prior to, during, and after anthracycline chemotherapy compared to placebo.
Study data will be collected and managed using the Ascension installation of REDCap (Research
Electronic Data Capture). REDCap is a secure, web application designed to support data
capture for research studies, providing user-friendly web-based case report forms, real-time
data entry validation (e.g. for data types and range checks), audit trails and a
de-identified data export mechanism to common statistical packages.
Echocardiographic data will be stored in cine-loop format on a private, password protected
echocardiogram viewing software and analyzed by a separate blinded cardiologist.
Patients will be evaluated according to the standard oncologic evaluation. The treating
oncologist will make decisions on their treatment based on their personal standards and
clinical judgement.