|

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

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

Inova Schar Cancer
Fairfax, Virginia, 22031
Keary Jane't571-472-3173keary.janet@inova.org
Inova Health Care Service
Falls Church, Virginia, 22042
Keary Jane't571-472-3173keary.janet@inova.org

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.