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Early Screening and Treatment of Heart Complication in Sickle Cell Disease
RECRUITINGPhase 2Sponsored by Inova Health Care Services
Actively Recruiting
PhasePhase 2
SponsorInova Health Care Services
Started2025-10-07
Est. completion2026-06-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →
NCT07023666
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
Age: 18 Years+Healthy volunteers accepted
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
Conditions2
Heart DiseaseSickle Cell Disease
Locations2 sites
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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
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Actively Recruiting
PhasePhase 2
SponsorInova Health Care Services
Started2025-10-07
Est. completion2026-06-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →
NCT07023666