Development of a Genetic Algorithm to Predict Anthracycline-Induced Cardiomyopathy in Adult Patients
T
Todd Skaar
Primary Investigator
Overview
he purpose of this prospective study is to assess the accuracy of four previously-studied genetic variations to predict the development of cardiomyopathy (i.e., a disease of the heart muscle that reduces the ability of your heart to pump blood to your body) in adult subjects during or following treatment with anthracyclines. Anthracyclines are an important class of traditional chemotherapy medications and are used in various regimens for the treatment of breast cancer, leukemia, lymphoma, stomach cancer, ovarian cancer, and other cancer types.
Description
Our research approach will involve the development of a new AICM risk prediction score that includes genetic variations that have been identified in previous genetic association studies. Three of these mutations were discovered and validated by a Canadian team of researchers in children and adolescent subjects.2 To date, their ability to predict AICM in adult subjects is not known.
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
cardiomyopathy
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Age: Between 18 Years - 100 Years
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Gender: All
Inclusion Criteria:
- inclusion criteria - eligibility criteria for subjects.
- 1. Greater than or equal to 18 years of age
- 2. Subjects with a known history of cancer receiving at least one dose of anthracycline chemotherapy, consisting of treatment with daunorubicin, doxorubicin, epirubicin, idarubicin, and/or mitoxantrone
- 3. Asymptomatic patient or symptomatic subjects with a left ventricular ejection fraction (LVEF) value as a decrease in the LVEF of >10 percentage points, to a value <53% as measured by echocardiography or cardiac MRI.4
- 4. Development of symptoms consistent with heart failure regardless of changes in ejection fraction, including (1) patients who go from American College of Cardiology(ACC)/American Heart Association (AHA) Stage A/B heart failure to ACC/AHA Stage C/D heart failure5 and (2) those with established diagnosis of heart failure with preserved ejection fraction (HFpEF) or heart failure with reduced ejection fraction (HFrEF).
- 5. Subjects presenting with symptoms of heart failure with elevated biomarker levels including natriuretic peptide biomarkers (BNP or NT-proBNP)5
- 6. Subjects presenting with symptoms of heart failure with changes in global longitudinal strain (GLS) with a 10% to 15% early reduction in GLS from baseline4,6
Exclusion Criteria:
- 1. Patients with a known history of ischemic cardiomyopathy with known coronary artery disease and a resultant decreased ejection fraction.
- 2. Patients with a known history of genetic, infiltrative, and/or infectious cardiomyopathy and a resultant decreased ejection fraction.
- 3. Vulnerable subjects, including children, pregnant women, fetuses, prisoners, mentally disabled persons, or economically or educationally disadvantaged persons.
- 4. Patients with diagnoses of heart failure with reduced ejection fraction or systolic heart failure before receiving their first anthracycline dose.
Updated on
27 Apr 2024.
Study ID: 2002384982
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