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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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.
Deferasirox is used for iron chelation therapy based on iron burden assessment throughout the study.
Deferiprone is used for iron chelation therapy used throughout the study.
Inova Schar Cancer
Fairfax, Virginia, United States
RECRUITINGInova Health Care Service
Falls Church, Virginia, United States
RECRUITINGIncidence of Hospitalization for Sickle Cell Disease Related Complications
Total number of participants hospitalized for SCD related complications including vaso-occlusive crises, acute chest syndrome and infection detect the impact of early intervention of cardiac iron overload in patients with Sickle Cell Disease
Time frame: Up to 12 months
Length of Stay for SCD-Related Complications
The total number of days spent in the hospital per admission for complications related to SCD.
Time frame: Up to 12 Months
Incidence of Left and/or Right Heart Failure
Total number of participants who develop left and/or right heart failure is estimated using descriptive statistics with 95% confidence intervals.
Time frame: Up to 12 Months
Incidence of Atrial or Ventricular Arrhythmia or Conduction Abnormalities
The number of participants with conditions such as atrial fibrillation, ventricular tachycardia, or conduction system disease. Reported with 95% confidence intervals.
Time frame: Up to 12 Months
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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.
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.