Early Screening and Treatment of Heart Complication in Sickle Cell Disease
Part of paid clinical trials in Fairfax, Virginia.
- Sponsor
- Inova Health Care Services
- Study ID
- NCT07023666
- Phase
- PHASE2
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Deferoxamine — DRUGDeferoxamine is used to reduce excess iron accumulation after monitoring iron levels. Adjustment to therapy will be based on iron burden assessments throughout the study duration.
- Deferasirox — DRUGDeferasirox is used for iron chelation therapy based on iron burden assessment throughout the study.
- Deferiprone — DRUGDeferiprone is used for iron chelation therapy used throughout the study.
- Echocardiography — DEVICEThis device uses ultrasound waves to create images of heart to help evaluate the heart's structure and function. This allows the detection of abnormalities of heart due to iron overload through out the study.
- Electrocardiogram (ECG) — DEVICEThe Electrocardiogram (ECG) device records the electrical activity of the heart. It is crucial for identifying arrhythmias and conduction abnormalities, which can be exacerbated by iron accumulation in the heart.
Study Details
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.
Key Dates
- Start date
- Oct 7, 2025
- Status verified
- Oct 2025
- Primary completion
- Jun 30, 2026
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Intervention for Cardiac Iron Overload in Sickle Cell PatientsThe study intervention consists of regular cardiac monitoring, iron chelation therapy and guideline-directed medical therapy (GDMT).
Primary Outcome Measure
Incidence of Hospitalization for Sickle Cell Disease Related Complications [ Time Frame: Up to 12 months ]
Central Contacts
- Keary Jane't571-472-3173keary.jane'[email protected]
- Elahe Mollapour571-472-0615
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Inova Schar Cancer | Fairfax | Virginia | 22031 | Sheinei Alan, MD (PRINCIPAL_INVESTIGATOR) |
| Inova Health Care Service | Falls Church | Virginia | 22042 | Sheinei Alan, MD (PRINCIPAL_INVESTIGATOR) |
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