Prophylactic Lisinopril to Prevent Anthracycline Cardiomyopathy.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03392740|
Recruitment Status : Unknown
Verified February 2018 by Andrew Hinojos, Ascension Genesys Hospital.
Recruitment status was: Not yet recruiting
First Posted : January 8, 2018
Last Update Posted : February 22, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Cardiomyopathy Due to Drug Heart Failure, Systolic||Drug: Lisinopril Drug: Placebo Oral Tablet||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective, 1:1 randomized, double-blinded and placebo-controlled clinical trial we plan to enroll patients who are to be treated with anthracycline chemotherapy to either lisinopril or placebo group.|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Prophylactic Lisinopril to Prevent Anthracycline Induced Left Ventricular Systolic Dysfunction (PLAID) Study.|
|Estimated Study Start Date :||March 15, 2018|
|Estimated Primary Completion Date :||March 15, 2019|
|Estimated Study Completion Date :||March 15, 2020|
Experimental: Lisinopril treatment
These patients will be initiated at 5mg lisinopril daily by the research nurse at the time of enrollment. The drug will then be titrated up by the research nurse in a stepwise fashion from 5mg, to 10mg, and then to 20mg once a day every 1 to 3 weeks according to their regular/scheduled next office visits. Blood pressure will be monitored at every visit by the research nurse if it is less than or equal to 90 mmHg
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.
Placebo Comparator: Placebo Oral Tablet
These patients will be started on the placebo medication at the time of enrollment. According to their regular scheduled visits every 1 to 3 weeks, they will meet with the research nurse and be given a new placebo medication to take once a day.
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.
- Change in strain rate from baseline [ Time Frame: 12 months from enrollment ]The primary outcome is a change in strain and strain rate from baseline echocardiogram
- Heart failure and left ventricular dysfunction [ Time Frame: 12 months from enrollment ]A decrease in ejection fraction >10% below 53% from baseline with at least 2 signs and symptoms of heart failure (lower extremity swelling, elevated jugular venous pulsation, orthopnea, paroxysmal nocturnal dyspnea, dyspnea on exertion). In those with an ejection fraction <53% at baseline will be placed in the primary endpoint if their ejection fraction decreases by >10% from their baseline with at least 2 signs and/or symptoms of heart failure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03392740
|Contact: Andrew Hinojos, DOfirstname.lastname@example.org|
|Contact: Thomas Miller, DOemail@example.com|
|Principal Investigator:||Andrew Hinojos, DO||Genesys Regional Medical Center Department of Education|