Recruiting
Phase 2

Heart Screening

Sponsor:

Inova Health Care Services

Code:

NCT07023666

Conditions

Sickle Cell Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Deferoxamine

Deferasirox

Deferiprone

Echocardiography

Electrocardiogram (ECG)

Study Details

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.

Conditions

Sickle Cell Disease

Study ID

NCT07023666

Start date

Oct 7, 2025

Status verified date

Sep, 2026

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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).

Interventions

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.

Deferasirox

Deferasirox is used for iron chelation therapy based on iron burden assessment throughout the study.

Deferiprone

Deferiprone is used for iron chelation therapy used throughout the study.

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.

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 measure

  • Incidence of Hospitalization for Sickle Cell Disease Related Complications [ Time Frame: Up to 12 months ]
  • Length of Stay for SCD-Related Complications [ Time Frame: Up to 12 Months ]

Central Contacts and Locations

Central contacts

Keary Jane't

571-472-3173keary.jane't@inova.org

Elahe Mollapour

571-472-0615elahe.mollapour@inova.org

Locations

Inova Schar Cancer

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Keary Jane't

571-472-3173keary.janet@inova.org

Principal Investigator:

Sheinei Alan, MD

Inova Health Care Service

Recruiting

Falls Church, Virginia, United States, 22042

Contacts

Keary Jane't

571-472-3173keary.janet@inova.org

Elahe Mollapour

571-472-0615elahe.mollapour@inova.org

Principal Investigator:

Sheinei Alan, MD

More Information

Sponsor

Inova Health Care Services

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

  • Iron Overload
  • Cardiomyopathies
  • Arrhythmias

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Inova Health Care Services on 2026-09-09.