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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
Sponsor:
Information provided by (Responsible Party):
Andrew Hinojos, Ascension Genesys Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Cardiomyopathy Due to Drug Heart Failure, Systolic Drug: Lisinopril Drug: Placebo Oral Tablet Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
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)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

Drug Information available for: Lisinopril

Arm Intervention/treatment
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
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.

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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Andrew Hinojos, DO 602-399-1174 andrew.hinojos@ascension.org
Contact: Thomas Miller, DO thomas.miller@ascension.org

Locations
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United States, Michigan
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439
Contact: Andrew A Hinojos    602-399-1174    andrew.hinojos@ascension.org   
Contact: Thomas Miller       thomas.miller@ascension.org   
Sponsors and Collaborators
Ascension Genesys Hospital
Investigators
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Principal Investigator: Andrew Hinojos, DO Genesys Regional Medical Center Department of Education
Publications:

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Responsible Party: Andrew Hinojos, Cardiology Fellow, Ascension Genesys Hospital
ClinicalTrials.gov Identifier: NCT03392740    
Other Study ID Numbers: GHIGHCI2018
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It is undecided at this point and there currently is not a plan to make individual participant data (IPD) collected in this study available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Cardiomyopathies
Heart Failure, Systolic
Heart Failure
Heart Diseases
Cardiovascular Diseases
Lisinopril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs