[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594762":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":31,"studyPopulation":24,"armGroups":32,"interventions":43,"overallOfficials":72,"centralContacts":77,"locations":87,"responsibleParty":119,"collaborators":24,"id":121,"slug":24,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":24,"eligibilityCriteria":126,"healthyVolunteers":122,"sex":127,"minAge":128,"maxAge":24,"enrollmentInfo":129,"targetDuration":24,"studyType":132,"phases":133,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":90,"whyStopped":24,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"Inova Health Care Services","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":24},[9,13],{"measure":10,"description":11,"timeFrame":12},"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","Up to 12 months",{"measure":14,"description":15,"timeFrame":16},"Length of Stay for SCD-Related Complications","The total number of days spent in the hospital per admission for complications related to SCD.","Up to 12 Months",[18,21],{"measure":19,"description":20,"timeFrame":16},"Incidence of Left and\u002For Right Heart Failure","Total number of participants who develop left and\u002For right heart failure is estimated using descriptive statistics with 95% confidence intervals.",{"measure":22,"description":23,"timeFrame":16},"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.",null,{"allocation":26,"interventionModel":27,"interventionModelDescription":24,"primaryPurpose":28,"observationalModel":24,"timePerspective":24,"maskingInfo":29},"NA","SINGLE_GROUP","TREATMENT",{"masking":30,"maskingDescription":24,"whoMasked":24},"NONE","The goal of the study is to detect iron-related heart problems in subjects with sickle cell disease (SCD) through regular cardiac imaging (electrocardiogram, echocardiogram, cardiac MRI) and lab testing every 3 months during the 12 months period. The treatment will be with iron chelation and guideline-directed heart medications.",[33],{"label":34,"type":35,"description":36,"interventionNames":37},"Intervention for Cardiac Iron Overload in Sickle Cell Patients","EXPERIMENTAL","The study intervention consists of regular cardiac monitoring, iron chelation therapy and guideline-directed medical therapy (GDMT).",[38,39,40,41,42],"Drug: Deferoxamine","Drug: Deferasirox","Drug: Deferiprone","Device: Echocardiography","Device: Electrocardiogram (ECG)",[44,51,57,63,68],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"DRUG","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.",[34],[50],"Desferal",{"type":45,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"Deferasirox","Deferasirox is used for iron chelation therapy based on iron burden assessment throughout the study.",[34],[56],"Jadenu, Exjade",{"type":45,"name":58,"description":59,"armGroupLabels":60,"otherNames":61},"Deferiprone","Deferiprone is used for iron chelation therapy used throughout the study.",[34],[62],"Ferriprox",{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":24},"DEVICE","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.",[34],{"type":64,"name":69,"description":70,"armGroupLabels":71,"otherNames":24},"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.",[34],[73],{"name":74,"affiliation":75,"role":76},"Sheinei Alan, MD","Inova Fairfax Hospital","PRINCIPAL_INVESTIGATOR",[78,83],{"name":79,"role":80,"phone":81,"phoneExt":24,"email":82},"Keary Jane't","CONTACT","571-472-3173","keary.jane't@inova.org",{"name":84,"role":80,"phone":85,"phoneExt":24,"email":86},"Elahe Mollapour","571-472-0615","elahe.mollapour@inova.org",[88,106],{"facility":89,"status":90,"city":91,"state":92,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":101,"contacts":102},"Inova Schar Cancer","RECRUITING","Fairfax","Virginia","22031","United States","US",{"type":97,"coordinates":98},"Point",[99,100],-77.30637,38.84622,{"lat":100,"lon":99},[103,105],{"name":79,"role":80,"phone":81,"phoneExt":24,"email":104},"keary.janet@inova.org",{"name":74,"role":76,"phone":24,"phoneExt":24,"email":24},{"facility":107,"status":90,"city":108,"state":92,"zip":109,"country":94,"countryCode":95,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Inova Health Care Service","Falls Church","22042",{"type":97,"coordinates":111},[112,113],-77.17109,38.88233,{"lat":113,"lon":112},[116,117,118],{"name":79,"role":80,"phone":81,"phoneExt":24,"email":104},{"name":84,"role":80,"phone":85,"phoneExt":24,"email":86},{"name":74,"role":76,"phone":24,"phoneExt":24,"email":24},{"type":120,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100594762",false,"NCT07023666","Early Screening and Treatment of Heart Complication in Sickle Cell Disease","Early Detection and Management of Cardiac Iron Overload in Sickle Cell Disease Using Multimodal Imaging for Improved Clinical Outcomes","Inclusion Criteria:\n\n* At least 18 years of age\n* Diagnosis of sickle cell disease (any genotype)\n* Serum ferritin levels ≥ 400 ng\u002FmL (up to 80 patients), or less than 400 ng\u002FmL in those who have cardiac symptoms including shortness of breath and lower extremity edema (up to 20 patients)\n* Willingness to undergo regular imaging (echocardiograms, ECG, cardiac MRI)\n* ECOG performance status of 0-1\n* Able to read, understand and provide written informed consent\n* Deemed appropriate for participation by the treating physician\n\nExclusion Criteria:\n\n* Unable to schedule and required follow-up visits\n* Medical comorbidities including:\n* Known heart failure\n* Unstable angina\n* Uncontrolled dysrhythmias\n* Acute pulmonary embolism\n* Active infection or severe comorbid conditions that in the view of the investigator would limit participation\n* History of hypersensitivity or contraindication to chelation therapy\n* Severe renal or hepatic impairment\n* Pregnancy of breastfeeding","ALL","18 Years",{"count":130,"type":131},100,"ESTIMATED","INTERVENTIONAL",[134],"PHASE2","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.",[137],"Sickle Cell Disease",[139,140,141],"Iron Overload","Cardiomyopathies","Arrhythmias","2025-10-09",{"date":144,"type":145},"2025-10-14","ACTUAL",{"date":147,"type":145},"2025-10-07",{"date":149,"type":131},"2027-06-30",{"name":5,"class":6},2]