RecruitingPhase 2NCT07023666

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

Sponsor

Inova Health Care Services

Enrollment

100 participants

Start Date

Oct 7, 2025

Study Type

INTERVENTIONAL

Conditions

Sickle Cell Disease

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

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 Criteria10

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

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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.