Development of a Genetic Algorithm to Predict Anthracycline-Induced Cardiomyopathy in Adult Patients
Todd Skaar
Primary Investigator
Brief description of study
Detailed description of study
- Subjects will be recruited from the Cardio-Oncology clinical practices at Krannert Institute of Cardiology. Subjects will be approached during clinic visits for enrollment in the study if they meet the eligibility criteria.
- Enrollment into the study will involve reviewing and signing an electronic informed consent document and providing 1-2 blood samples (approximately 1 teaspoon each; an additional sample will be drawn if subjects consent to have a specimen stored in the Indiana Biobank) to enable an analysis of patient genetic information.
- There is a small chance that the researchers may not be able to isolate DNA from the research blood sample. If this occurs, the researchers may re-contact the subjects and, with their permission, collect an additional blood sample from the subject at a future Indiana University Health Physicians Cardiology clinic visit.
- Subjects will also complete the Minnesota Living With Heart Failure Questionnaire, a validated and widely used survey to assess health-related quality of life in heart failure patients, at the time of enrollment. Subjects will complete the survey via RedCap on the tablet presented to them. The survey will take approximately 20-30 minutes to complete. Once enrolled in the study, there will be no follow-up interactions with subjects.
- All clinical data will be collected via screening of subjects’ electronic health records.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Anthracycline chemotherapy, Left ventricular ejection fraction, LVEF, Cardiomyopathy
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Age: Between 18 Years - 100 Years
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Gender: All
Inclusion critiera
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
7. Ability to read and comprehend English and to provide written, informed consent.
*Subjects must meet criteria 1, 2, and 7 and one of criteria 3, 4, 5, or 6 to be eligible.
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.
