Prophylactic Lisinopril to Prevent Anthracycline Cardiomyopathy.

• Status: Unknown status
• Trial end date: 2020-03-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ascension Genesys Hospital
• Treatments: Lisinopril

Criteria

Inclusion Criteria:

• Diagnosed with a type of cancer and intended to be on an anthracycline chemotherapy regimen by treating oncologist.

Exclusion Criteria:

• Inability or unwillingness to give informed consent

• Subjects with a contraindication to angiotensin converting enzyme inhibitors such as history of angioedema or hypersensitivity related to previous treatment with an angiotensin converting enzyme inhibitor

• Subjects with a history of hereditary or idiopathic angioedema

• Subjects currently taking aliskiren (major drug interaction-)

• Subjects currently taking a neprilysin inhibitor (e.g. sacubitril or entresto)

• Subjects already on treatment with angiotensin converting enzyme inhibitors, or taking lithium

• Renal insufficiency defined as creatinine clearance <30

• Women <50 who capable of child bearing who have not had surgical contraception such as hysterectomy or tubal ligation

• Oncologic life expectancy shorter than 12 months

• Systolic blood pressure <90 mmHg prior to enrollment