Early Screening and Treatment of Heart Complication in Sickle Cell Disease

Phase 2

Not yet recruiting

• Conditions: Sickle Cell Disease
• Interventions: Drug: Deferoxamine; Drug: Deferasirox; Drug: Deferiprone; Device: Echocardiography; Device: Electrocardiogram (ECG)

• Registration Number: NCT07023666
• Lead Sponsor: Inova Health Care Services

Brief 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.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-09
• Study First Submitted QC: 2025-06-09
• Last Update Submitted: 2025-06-09
• Study First Posted: 2025-06-17
• Last Update Posted: 2025-06-17
• Study Start: 2025-06-30
• Primary Completion: 2026-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention for Cardiac Iron Overload in Sickle Cell Patients	Deferoxamine	The study intervention consists of regular cardiac monitoring, iron chelation therapy and guideline-directed medical therapy (GDMT).
Intervention for Cardiac Iron Overload in Sickle Cell Patients	Deferasirox	The study intervention consists of regular cardiac monitoring, iron chelation therapy and guideline-directed medical therapy (GDMT).
Intervention for Cardiac Iron Overload in Sickle Cell Patients	Deferiprone	The study intervention consists of regular cardiac monitoring, iron chelation therapy and guideline-directed medical therapy (GDMT).
Intervention for Cardiac Iron Overload in Sickle Cell Patients	Echocardiography	The study intervention consists of regular cardiac monitoring, iron chelation therapy and guideline-directed medical therapy (GDMT).
Intervention for Cardiac Iron Overload in Sickle Cell Patients	Electrocardiogram (ECG)	The study intervention consists of regular cardiac monitoring, iron chelation therapy and guideline-directed medical therapy (GDMT).

Primary Outcome Measures

Name	Time	Method
Length of Stay for SCD-Related Complications	Up to 12 Months	The total number of days spent in the hospital per admission for complications related to SCD.
Incidence of Hospitalization for Sickle Cell Disease Related Complications	Up to 12 months	Total number of participants hospitalized for SCD related complications including vaso-occlusive crises, acute chest syndrome and infection detect the impact of early intervention of cardiac iron overload in patients with Sickle Cell Disease

Secondary Outcome Measures

Name	Time	Method
Incidence of Left and/or Right Heart Failure	Up to 12 Months	Total number of participants who develop left and/or right heart failure is estimated using descriptive statistics with 95% confidence intervals.
Incidence of Atrial or Ventricular Arrhythmia or Conduction Abnormalities	Up to 12 Months	The number of participants with conditions such as atrial fibrillation, ventricular tachycardia, or conduction system disease. Reported with 95% confidence intervals.

Trial Locations

Locations (1)

Inova Health Care Service; 🇺🇸 Falls Church, Virginia, United States