[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597052":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":35,"locations":45,"responsibleParty":63,"collaborators":67,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":34,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":95,"overallStatus":48,"whyStopped":34,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Western Kentucky Heart and Lung Research Foundation and Educational Trust","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"IV Iron (Ferric Carboxymaltose)","EXPERIMENTAL","Patients randomized to receive intravenous ferric carboxymaltose. Dosing includes a 1-gram IV infusion during the index hospital stay, followed by a second infusion at Week 6 (1,000 mg if \\> 70 kg or 500 mg if ≤ 70 kg).",[13],"Drug: Ferric Carboxymaltose",{"label":15,"type":16,"description":17,"interventionNames":18},"Oral Iron (Ferrous Sulfate)","ACTIVE_COMPARATOR","Patients randomized to receive one capsule of oral ferrous sulfate (Ferrex 150 mg) every 48 hours for 12 weeks.",[19],"Drug: Ferrous Sulfate",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Ferric Carboxymaltose","Intravenous infusion of 1 gram FCM during index hospital stay, followed by a second dose at Week 6 (1,000 mg if \\> 70 kg or 500 mg if ≤ 70 kg).",[9],[27],"FCM, IV Iron",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Ferrous Sulfate","Oral administration of one 150 mg capsule every 48 hours for 12 weeks.",[15],[33],"Ferrex, Oral Iron",null,[36,41],{"name":37,"role":38,"phone":39,"phoneExt":34,"email":40},"Syed H Mufarrih, MD","CONTACT","304-598-4218","hamzamufarrih@live.com",{"name":42,"role":38,"phone":43,"phoneExt":34,"email":44},"Melinda Joyce","(270) 535-6879","JoycMC@MCHealth.net",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"The Medical Center","RECRUITING","Bowling Green","Kentucky","42101","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-86.4436,36.99032,{"lat":58,"lon":57},[61],{"name":62,"role":38,"phone":43,"phoneExt":34,"email":44},"Melinda Joyce, PharmD, FAPhA, FACHE",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"SPONSOR_INVESTIGATOR","Syed Hamza Mufarrih","Principal Investigator",[68],{"name":69,"class":70},"American Regent, Inc.","INDUSTRY","100597052","phase-4-ironica-iron-repletion-in-heart-failure---a-comparison-of-oral-and-iv-approaches-100597052",false,"NCT07053475","IRONICA: IRON Repletion In Heart Failure - A Comparison of Oral and IV Approaches","IRONICA: IRON Repletion in Congestive Heart Failure - A Randomized Controlled Trial Comparing Oral Versus IV Approaches","IRONICA","Inclusion Criteria:\n\n* Age ≥18 years\n* BMI ≥18.0 kg\u002Fm²\n* Hemoglobin:\n\n\\> 9 g\u002FdL and \\\u003C14 g\u002FdL for men \\> 9 g\u002FdL and \\\u003C13 g\u002FdL for women\n\n* Diagnosed with Congestive Heart failure:\n\nHFrEF: EF ≤40% in any recent echocardiogram HFpEF: EF ≥50-55% without any prior EF ≤40%, and evidence of diastolic dysfunction per ASE\u002FEACVI 2023 criteria-defined as either grade ≥2 or ≥2 supporting echo parameters (septal e' \\\u003C7 cm\u002Fsec or lateral e' \\\u003C10 cm\u002Fsec, E\u002Fe' ≥15, TR velocity \\>2.8 m\u002Fs, LA volume index ≥34 mL\u002Fm², LV septal or posterior wall thickness ≥1.2 cm, or LA area ≥20 cm² \u002F diameter ≥3.8 cm.\n\n* Documented elevated NT-proBNP based on BMI and rhythm:\n\nBMI \\\u003C35: ≥220 pg\u002FmL (NSR) or ≥660 pg\u002FmL (A-Fib) BMI ≥35: ≥125 pg\u002FmL (NSR) or ≥375 pg\u002FmL (A-Fib)\n\n* NYHA Class II-IV\n* Transferrin saturation (TSAT) \\\u003C20%\n* Hemoglobin \\\u003C14 g\u002FdL for men, \\\u003C 13 g\u002FdL for women.\n* Stable on heart failure therapy for ≥2-4 weeks\n* Currently prescribed a diuretic at home\n* Ambulatory (able to walk \\>20 ft with minimal assistance)\n* Willing and able to give informed consent\n\nExclusion Criteria:\n\n* Received IV iron, ESA, or blood transfusion within the last 6-12 months\n* Received high-dose oral iron (\\>100 mg\u002Fday in past 7 days)\n* Severe renal impairment (eGFR \\\u003C15 mL\u002Fmin\u002F1.73 m² or on dialysis)\n* Patients with known cirrhosis or transaminitis with AST \\>141 or ALT \\>112 IU\u002FL\n* Active bleeding or known bleeding disorder\n* Recent cardiac surgery, myocardial infarction, or stroke within past 3 months\n* Active infection, defined as any systemic or deep-seated infection (e.g., bacteremia, sepsis, osteomyelitis, or infections requiring IV antibiotics or hospitalization) at the time of screening.\n* Active malignancy or undergoing chemotherapy\u002Fradiotherapy\n* Vitamin B12 or folate deficiency (unless corrected prior to enrollment)\n* Chronic liver disease (with LFTs \\>3× upper limit of normal)\n* Pregnant or breastfeeding women or those not using effective contraception\n* Lacks capacity to consent or unable to comply with study procedures","ALL","18 Years","100 Years",{"count":83,"type":84},250,"ESTIMATED","INTERVENTIONAL",[87],"PHASE4","The goal of this clinical trial is to learn which iron treatment works better for adults with congestive heart failure and low iron levels: intravenous (IV) iron given through a vein or oral (PO) iron taken by mouth. Participants must have heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF) and a transferrin-saturation (TSAT) level below 20 percent.\n\nThe main questions the study will answer are:\n\n1. Does IV iron raise walking distance on a 6-minute walk test more than oral iron after 24 weeks?\n2. Does IV iron improve symptoms and quality of life more than oral iron?\n3. How do the two treatments compare for safety, side effects, and hospital readmissions\u002F mortality?\n\nResearchers will compare IV ferric carboxymaltose with oral ferrous sulfate to see which option helps people feel and function better.\n\nWhat participants will do\n\n* Be randomly assigned by (like flipping a coin) to IV iron or oral iron.\n* Receive either a one-time IV iron infusion (with possible repeat at 12 weeks) or take iron pills twice each day for 24 weeks.\n* Visit the infusion clinic at 6 weeks for second dose of IV iron if needed.\n* Visit the clinic at 12 weeks for a follow-up to gather follow-up data including\n\n  1. A 6-minute walk test\n  2. Brief symptom and quality-of-life surveys\n  3. Blood tests to measure serum iron, ferritin, and transferrin saturation\n\nThis study will help doctors decide whether IV or oral iron is the safer, more effective way to treat iron deficiency in people with heart failure in our local community.",[90,91,92,93,94],"Heart Failure","Heart Failure With Reduced Ejection Fraction (HFrEF)","Heart Failure With Preserved Ejection Fraction (HFPEF)","Iron Deficiency","Iron-deficiency Anemia (IDA)",[96,97,98,99,100,101,102,103,104,105,106,107,108],"Intravenous iron","Oral iron","Ferric carboxymaltose","Ferrous sulfate","Transferrin saturation (TSAT)","Functional iron deficiency","6-minute walk test (6MWT)","Kansas City Cardiomyopathy Questionnaire (KCCQ)","Quality of life","Randomized controlled trial","Congestive heart failure","HFpEF","HFrEF","2025-06-26",{"date":111,"type":112},"2025-07-08","ACTUAL",{"date":114,"type":112},"2025-04-02",{"date":116,"type":84},"2027-03-31",{"name":65,"class":6},1]