NCT07023666PHASE2Recruiting
Early Screening and Treatment of Heart Complication in Sickle Cell Disease
Inova Health Care Services
Start Date
10/7/2025
Completion Date
6/30/2027
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.
Detailed 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 Criteria
Age Range: 18 years to No maximum
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
Interventions
DRUG
Deferoxamine
DRUG
Deferasirox
DRUG
Deferiprone
DEVICE
Echocardiography
DEVICE
Electrocardiogram (ECG)
Conditions
Sickle Cell Disease
Locations
Inova Schar Cancer
Fairfax, Virginia 22031
United States
Inova Health Care Service
Falls Church, Virginia 22042
United States