Early Screening and Treatment of Heart Complication in Sickle Cell Disease
Recruiting · NCT07023666 · Interventional (participants receive a specific treatment) · Lead sponsor: Inova Health Care Services
View the official record on ClinicalTrials.gov →Interventions studied
DeferasiroxDeferiproneDeferoxamineEchocardiographyElectrocardiogram (ECG)
What this trial is about
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 can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
2 locations listed across 1 US state.
- Inova Schar Cancer - Fairfax, Virginia, United States
- Inova Health Care Service - Falls Church, Virginia, United States