Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-24 @ 4:25 PM
NCT ID:
NCT07023666
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07023666
Study Brief:
Protocol Section:
NCT07023666