Early heart screening and treatment for people with sickle cell disease
Official title: Early Detection and Management of Cardiac Iron Overload in Sickle Cell Disease Using Multimodal Imaging for Improved Clinical Outcomes
Run by Inova Health Care Services · NCT07023666 · Data updated 2026-11-12
This study tests whether regular heart checks and early iron-removing treatment can prevent heart problems and cut hospital stays in adults with sickle cell disease who have high iron or heart symptoms.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Inova Health Care Services Academic / other |
| Locations | 2 sites (Fairfax, Virginia and 1 other locations) |
| Status | Recruiting |
| Started | October 7, 2025 |
| Main results expected | June 30, 2027 |
| Study ends | December 30, 2027 |
| Registry record updated | September 9, 2026 |
| Trial ID | NCT07023666 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with any sickle cell genotype who are willing to undergo regular cardiac imaging and follow-up, with ferritin ≥ 400 ng/mL (or lower ferritin with cardiac symptoms), and ECOG 0–1 are ideal candidates.
✕Probably not a fit
People with known heart failure, unstable angina, uncontrolled arrhythmias, severe renal or liver impairment, contraindication to chelation, active severe infections, pregnancy or inability to attend follow-up are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants will have cardiac imaging (ECG, echocardiogram, cardiac MRI) and lab testing every three months for one year to look for iron-related heart problems. Those with evidence of iron overload or cardiac findings may receive iron chelation (deferoxamine, deferasirox, or deferiprone) and guideline-directed heart medications. The trial enrolls adults with sickle cell disease, including up to about 80 people with ferritin ≥ 400 ng/mL and up to 20 with lower ferritin but cardiac symptoms. Outcomes include development or progression of cardiac complications and rates of hospitalization over the 12-month period.
Why it matters
Potential benefit: If successful, this approach could prevent iron-related heart damage and reduce hospitalizations for adults with sickle cell disease.
How similar studies have gone: Iron chelation and routine cardiac screening have improved cardiac outcomes in transfusion-dependent conditions like thalassemia, but their specific benefit in sickle cell disease is less well established.
Who can join: the full rules
Show full inclusion / exclusion criteria
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's running
-
Inova Schar Cancer
Fairfax, Virginia, United States Recruiting -
Inova Health Care Service
Falls Church, Virginia, United States Recruiting
Study contacts
- Principal investigator: Sheinei Alan, MD — Inova Fairfax Hospital
- Study coordinator: Keary Jane't
- Email: keary.jane't@inova.org
- Phone: 571-472-3173
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.