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 — DRUG
    Deferoxamine 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 — DRUG
    Deferasirox is used for iron chelation therapy based on iron burden assessment throughout the study.
  • Deferiprone — DRUG
    Deferiprone is used for iron chelation therapy used throughout the study.
  • Echocardiography — DEVICE
    This 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) — DEVICE
    The 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 Patients
    The 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

Locations (2)

FacilityCityStateZIPSite coordinators
Inova Schar CancerFairfaxVirginia22031
Keary Jane't
571-472-3173
Sheinei Alan, MD (PRINCIPAL_INVESTIGATOR)
Inova Health Care ServiceFalls ChurchVirginia22042
Keary Jane't
571-472-3173
Elahe Mollapour
571-472-0615
Sheinei Alan, MD (PRINCIPAL_INVESTIGATOR)

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