Prophylactic Lisinopril to Prevent Anthracycline Cardiomyopathy.

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.

Conditions

• Cardiomyopathy Due to Drug
• Heart Failure, Systolic

Interventions

DRUG

Lisinopril

Patients will be given lisinopril once a day prior to starting an anthracycline chemotherapy regimen and titrated up in a stepwise fashion, as allowed by patients blood pressure, to a target dose of 20mg daily.

DRUG

Placebo Oral Tablet

Patients will be given a look-alike placebo medication once a day prior to starting an anthracycline chemotherapy regimen. They will be given a new placebo medication in a step-wise fashion over period of 1 to 3 weeks.

Sponsors & Collaborators

• Ascension Health

  lead INDUSTRY

Principal Investigators

• Andrew Hinojos, DO · Genesys Regional Medical Center Department of Education

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-03-15

Primary Completion

2018-12-15

Completion

2018-12-15

FDA Drug

Yes

Countries

• United States

Study Locations