Status:
WITHDRAWN
Prophylactic Lisinopril to Prevent Anthracycline Cardiomyopathy.
Lead Sponsor:
Ascension Health
Conditions:
Cardiomyopathy Due to Drug
Heart Failure, Systolic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 an...
Detailed Description
To date anthracycline chemotherapy regimens still play a major role in many cancer treatments, approximately 32% of breast cancer patients, 57-70% of elderly lymphoma patients, and 50-60% of childhood...
Eligibility Criteria
Inclusion
- Diagnosed with a type of cancer and intended to be on an anthracycline chemotherapy regimen by treating oncologist.
Exclusion
- 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
Key Trial Info
Start Date :
March 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03392740
Start Date
March 15 2018
End Date
December 15 2018
Last Update
May 20 2024
Active Locations (1)
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1
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439