Early Detection and Management of Cardiac Iron Overload in Sickle Cell Disease Using Multimodal Imaging for Improved Clinical Outcomes
Inova Health Care Services
Summary
This study tests whether early heart screening and treatment for iron overload in subjects with sickle cell disease can prevent heart problems and reduce hospitalizations.
Description
The goal of the study is to detect iron-related heart problems in subjects with sickle cell disease (SCD) through regular cardiac imaging (electrocardiogram, echocardiogram, cardiac MRI) and lab testing every 3 months during the 12 months period. The treatment will be with iron chelation and guideline-directed heart medications.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * At least 18 years of age * Diagnosis of sickle cell disease (any genotype) * Serum ferritin levels ≥ 400 ng/mL (up to 80 patients), or less than 400 ng/mL in those who have cardiac symptoms including shortness of breath and lower extremity edema (up to 20 patients) * Willingness to undergo regular imaging (echocardiograms, ECG, cardiac MRI) * ECOG performance status of 0-1 * Able to read, understand and provide written informed consent * Deemed appropriate for participation by the treating physician Exclusion Criteria: * Unable to schedule and required follow-up visits…
Interventions
- DrugDeferoxamine
Deferoxamine is used to reduce excess iron accumulation after monitoring iron levels. Adjustment to therapy will be based on iron burden assessments throughout the study duration.
- DrugDeferasirox
Deferasirox is used for iron chelation therapy based on iron burden assessment throughout the study.
- DrugDeferiprone
Deferiprone is used for iron chelation therapy used throughout the study.
- DeviceEchocardiography
This device uses ultrasound waves to create images of heart to help evaluate the heart's structure and function. This allows the detection of abnormalities of heart due to iron overload through out the study.
- DeviceElectrocardiogram (ECG)
The Electrocardiogram (ECG) device records the electrical activity of the heart. It is crucial for identifying arrhythmias and conduction abnormalities, which can be exacerbated by iron accumulation in the heart.
Locations (2)
- Inova Schar CancerFairfax, Virginia
- Inova Health Care ServiceFalls Church, Virginia