Health TrialsbyHealthPanel

Early Screening and Treatment of Heart Complication in Sickle Cell Disease

ConditionSickle Cell Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInova Health Care Services

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Unable to schedule and required follow-up visits

Known heart failure

Unstable angina

Uncontrolled dysrhythmias

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Intervention for Cardiac Iron Overload in Sickle Cell PatientsExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Incidence of Hospitalization for Sickle Cell Disease Related Complications

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

Time frame
Up to 12 months
2

Length of Stay for SCD-Related Complications

The total number of days spent in the hospital per admission for complications related to SCD.

Time frame
Up to 12 Months

Secondary outcomes

1

Incidence of Left and/or Right Heart Failure

Total number of participants who develop left and/or right heart failure is estimated using descriptive statistics with 95% confidence intervals.

Time frame
Up to 12 Months
2

Incidence of Atrial or Ventricular Arrhythmia or Conduction Abnormalities

The number of participants with conditions such as atrial fibrillation, ventricular tachycardia, or conduction system disease. Reported with 95% confidence intervals.

Time frame
Up to 12 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Inova Health Care Services

Lead sponsor

Source ClinicalTrials.gov
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