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RECRUITINGPhase 2INTERVENTIONAL

Early Screening and Treatment of Heart Complication in Sickle Cell Disease

Early Detection and Management of Cardiac Iron Overload in Sickle Cell Disease Using Multimodal Imaging for Improved Clinical Outcomes

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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) - You should be able to carry out daily activities with 0 level of ability (ECOG 0)-1 - Able to read, understand and provide written willing to sign a consent form - Deemed appropriate for participation by the treating physician Who Should NOT Join This Trial: - Unable to schedule and required follow-up visits - Medical comorbidities including: - Known heart failure - Unstable angina - Uncontrolled dysrhythmias - Acute pulmonary embolism - Active infection or severe comorbid conditions that in the view of the investigator would limit participation - History of hypersensitivity or contraindication to chelation therapy - Severe renal or hepatic impairment - Pregnancy of breastfeeding Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 * Medical comorbidities including: * Known heart failure * Unstable angina * Uncontrolled dysrhythmias * Acute pulmonary embolism * Active infection or severe comorbid conditions that in the view of the investigator would limit participation * History of hypersensitivity or contraindication to chelation therapy * Severe renal or hepatic impairment * Pregnancy of breastfeeding

Treatments Being Tested

DRUG

Deferoxamine

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.

DRUG

Deferasirox

Deferasirox is used for iron chelation therapy based on iron burden assessment throughout the study.

DRUG

Deferiprone

Deferiprone is used for iron chelation therapy used throughout the study.

DEVICE

Echocardiography

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.

DEVICE

Electrocardiogram (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 Cancer
Fairfax, Virginia, United States
Inova Health Care Service
Falls Church, Virginia, United States