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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Falls Church, Virginia, United States
Patients applied
Trial Officials
Sheinei Alan, MD
Principal Investigator
Inova Fairfax Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported