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Search / Trial NCT07023666

Early Screening and Treatment of Heart Complication in Sickle Cell Disease

Launched by INOVA HEALTH CARE SERVICES · Jun 9, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Iron Overload Cardiomyopathies Arrhythmias

ClinConnect Summary

This clinical trial is studying whether checking the heart early and treating iron buildup can help prevent heart problems and reduce hospital stays in people with sickle cell disease. People with sickle cell disease often receive blood transfusions, which can cause extra iron to build up in the body and harm the heart. This study aims to find out if catching and treating this iron overload early can keep the heart healthier.

Adults with sickle cell disease who are 18 years or older may be eligible to join, especially if they have higher iron levels in their blood or are showing heart-related symptoms like shortness of breath or swelling in the legs. Participants will have regular heart tests, such as ultrasounds, heart rhythm checks, and MRI scans, to monitor their heart health. The study will also provide treatments to reduce iron buildup when needed. It’s important that participants can attend all scheduled visits and don’t have serious existing heart problems or other health issues that might interfere with the study. This trial is not yet open for enrollment but aims to improve care for people living with sickle cell disease by focusing on heart health early on.

Gender

ALL

Eligibility criteria

  • 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

About Inova Health Care Services

Inova Health Care Services is a leading healthcare organization dedicated to providing high-quality, patient-centered care across a comprehensive range of medical specialties. With a commitment to advancing clinical research and innovation, Inova actively sponsors and conducts clinical trials aimed at improving health outcomes and enhancing treatment options for patients. The organization combines state-of-the-art facilities, a skilled team of medical professionals, and a robust research infrastructure to facilitate groundbreaking studies that address pressing health challenges. Through its dedication to excellence in clinical research, Inova Health Care Services strives to contribute to the evolving landscape of healthcare and improve the lives of individuals in the communities it serves.

Locations

Falls Church, Virginia, United States

Patients applied

0 patients applied

Trial Officials

Sheinei Alan, MD

Principal Investigator

Inova Fairfax Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported