NCT07023666 · Inova Health Care Services
Early Screening and Treatment of Heart Complication in Sickle Cell Disease
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
Incidence of Hospitalization for Sickle Cell Disease Related Complications
Time frame: 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
Length of Stay for SCD-Related Complications
Time frame: Up to 12 Months
The total number of days spent in the hospital per admission for complications related to SCD.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Fairfax, Virginia
- Falls Church, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 14, 2025 · Source of record for eligibility and locations