General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT07023666

Background Information

To evaluate the effect of early detection of cardiac structural and functional abnormalities associated with iron overload-related cardiotoxicity followed by early intervention in patients with sickle cell disease (SCD) as measured by incidence of hospitalization and length of stay for SCD-related complications. 

For more information, visit https://clinicaltrials.gov/study/NCT07023666

Offered At

Inova Schar Cancer Institute: 
8081 Innovation Park Drive
Fairfax, VA 22031
 

Fairfax Radiology Centers, LLC: 
8260 Willow Oaks Corporate Drive, Suite 750
Fairfax, VA 22031
 

Inova Fairfax Hospital:
3300 Gallows Road
Falls Church, VA 22042
 

Inova Fair Oaks Hospital:
3600 Joseph Siewick Drive
Fairfax, VA 22033
 

Inova Alexandria Hospital:
4320 Seminary Road
Alexandria, VA 22304
 

Inova Loudoun Hospital:
44045 Riverside Parkway
Leesburg, VA 20176
 
Principal Investigator

Sheinei Alan, MD, PhD

Eligibility Information

  • 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

Ineligibility Information

  • 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