Development of a Genetic Algorithm to Predict Anthracycline-Induced Cardiomyopathy in Adult Patients

T
Todd Skaar

Primary Investigator

Enrolling By Invitation
18 years - 100 years
All
Phase N/A
100 participants needed
3 Locations

Brief description of study

What is the purpose of this study?
The 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. 

THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.

Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

What will happen during the 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
  • Age: 18 years - 100 years
  • 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.

Updated on 01 Aug 2024. Study ID: KIC-IIR-CLASEN-AICM-RISK, 2002384982
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