Cardiotoxicity Assessment Through Comprehensive Heart Imaging to Predict Heart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age13-39
SponsorHari Narayan
About this trial
Anthracycline chemotherapies (e.g. doxorubicin, daunorubicin) are commonly given to treat pediatric cancer, and carry a risk of cardiotoxicity. Over the long term, children who receive these therapies have an increased risk of heart failure and early cardiovascular death. However, current strategies for identifying patients who are at risk prior to the development of significant changes in heart function are limited. This study will focus on imaging markers of cardiac injury and dysfunction with the goal of developing improved diagnostic tests and treatment strategies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
English and Spanish speaking male and female subjects, ages 13-39 years old
Diagnosis of cancer at age <22 years
Previously treated with anthracyline therapy for cancer, with diagnosis at least two years prior.
Disqualifiers
Patients who have a contraindication to cardiac MRI, including the presence of non-MRI compatible metallic implants.
Medical, psychiatric, and/or social disorder that would prevent successful completion of planned study testing or would preclude the subject from undergoing the cardiac MRI without anesthesia.
Patients with a history of congenital heart disease (more significant than a history of patent foramen ovale or patent ductus arteriosus).
Pregnancy (at the time of enrollment).
Trial population
Long-term childhood cancer survivors treated with anthracyline therapy.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Cardiac magnetic resonance imaging (MRI)
Diagnostic testCardiac magnetic resonance imaging will be performed to evaluate cardiac remodeling, function, and tissue characteristics
Accelerometer physical activity monitoring
Other interventionMeasurement of physical activity using hip-worn accelerometer.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: All Study Participants2 interventions
Trial outcomes
Primary outcomes
1
Left ventricular ejection fraction (LVEF)
LVEF is an assessment of left ventricular global systolic function.
Time frame
3 - 5 yearsSponsors and contacts
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Hari Narayan
Lead sponsor
University of California, San Diego
Sponsor institution
Source ClinicalTrials.gov