NCT07023666

Early Screening and Treatment of Heart Complication in Sickle Cell Disease

Early Detection and Management of Cardiac Iron Overload in Sickle Cell Disease Using Multimodal Imaging for Improved Clinical Outcomes

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Inova Health Care Services · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The goal of the study is to detect iron-related heart problems in subjects with sickle cell disease (SCD) through regular cardiac imaging (electrocardiogram, echocardiogram, cardiac MRI) and lab testing every 3 months during the 12 months period. The treatment will be with iron chelation and guideline-directed heart medications.

Conditions

• Sickle Cell Disease

Interventions

Type	Name	Description
DRUG	Deferoxamine	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.
DRUG	Deferasirox	Deferasirox is used for iron chelation therapy based on iron burden assessment throughout the study.
DRUG	Deferiprone	Deferiprone is used for iron chelation therapy used throughout the study.
DEVICE	Echocardiography	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.
DEVICE	Electrocardiogram (ECG)	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.

Timeline

• Start date: 2025-10-07
• Primary completion: 2026-06-30
• Completion: 2027-06-30
• First posted: 2025-06-17
• Last updated: 2025-10-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study