[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548926":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":35,"locations":45,"responsibleParty":63,"collaborators":34,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":34,"enrollmentInfo":75,"targetDuration":34,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":47,"whyStopped":34,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"China-Japan Friendship Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"High dose","EXPERIMENTAL","Participants randomized to this arm will receive repeat iron dosing as long as the serum ferritin was not \\>700 ng\u002FmL, or if TSAT was not \\>40% during follow-up.\n\nIron to be administered as ferric derisomaltose. Ferric derisomaltose will be administered according to the dosing schedule determined by the patient's body weight and hemoglobin value.\n\nInfused over a minimum of 15 mins for doses up to and including 1000mg, and a minimum of 30 mins for doses \\>1000mg.",[13],"Drug: High-dose ferric derisomaltose",{"label":15,"type":16,"description":17,"interventionNames":18},"Low dose","ACTIVE_COMPARATOR","Participants randomized to this arm will receive repeat iron dosing if ferritin \\\u003C100 ng\u002FmL or if ferritin 100-300 ng\u002FmL and TSAT \\\u003C20% during follow-up.\n\nIron to be administered as ferric derisomaltose in analogy to high-dose arm.",[19],"Drug: Low-dose ferric derisomaltose",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","High-dose ferric derisomaltose","After baseline assessment, participants will be randomized in a 1:1 ratio to receive a high-dose IV iron regimen and a low-dose IV iron regimen. After the initial iron repletion, ferritin concentration and TSAT were measured every three months and the results used to determine the dose of ferric derisomaltose during follow-up.\n\nIn the high-dose group, participants will receive repeat iron dosing as long as the serum ferritin was not \\>700 ng\u002FmL, or if TSAT was not \\>40% during follow-up.",[9],[27],"More intensive target",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Low-dose ferric derisomaltose","In the low-dose group, participants will receive repeat iron dosing if ferritin \\\u003C100 ng\u002FmL or if ferritin 100-300 ng\u002FmL and TSAT \\>20% during follow-up.",[15],[33],"Less intensive target",null,[36,41],{"name":37,"role":38,"phone":39,"phoneExt":34,"email":40},"Jingyi Ren","CONTACT","18600195099","renjingyi1213@hotmail.com",{"name":42,"role":38,"phone":43,"phoneExt":34,"email":44},"Lina Su","18801230212","sln920722@163.com",[46],{"facility":5,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","Beijing","Beijing Municipality","100044","China","CN",{"type":54,"coordinates":55},"Point",[56,57],116.39723,39.9075,{"lat":57,"lon":56},[60,61],{"name":42,"role":38,"phone":43,"phoneExt":34,"email":44},{"name":37,"role":62,"phone":34,"phoneExt":34,"email":34},"PRINCIPAL_INVESTIGATOR",{"type":62,"investigatorFullName":37,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Professor of medicine(Cardiology), Deputy Director of the Cardiology Department and Director of the Heart Failure Center","100548926","phase-4-the-effects-of-low-dose-versus-high-dose-intravenous-iron-therapy-with-ferric-derisomaltose-in-patients-with-chronic-heart-failure-and-iron-deficiency-100548926",false,"NCT06427343","The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency","The Effects of Low-dose Versus High-dose Intravenous Iron Therapy With Ferric Derisomaltose in Patients With Chronic Heart Failure and Iron Deficiency: a Randomized, Open-label, Blind Endpoint Trial (IRONDOSE)","IRONDOSE","Inclusion Criteria:\n\n1. Age \\>18 years.\n2. Left ventricular ejection fraction (LVEF) \\\u003C50% within 2 years prior to planned randomization (assessed by echocardiography or MRI).\n3. New York Heart Association (NYHA) class II \\~ III.\n4. Either hospitalization for HF within 6 months prior to planned randomization or elevated plasma levels of natriuretic peptides within 3 months of randomization. a. For patients in sinus rhythm: NT- proBNP \\>300 pg\u002FmL or BNP \\>100 pg\u002FmL. b. For patients in atrial fibrillation: NT-proBNP \\>600 pg\u002FmL or BNP \\>200 pg\u002FmL.\n5. Subjects with stable CHF (NYHA II\u002FIII functional class) on optimal background therapy (as determined by the investigator) for at least 4 weeks with no dose changes of heart failure drugs during the last 2 weeks (with the exception of diuretics).\n6. Serum ferritin \\\u003C100 ng\u002FmL or serum ferritin 100-300 ng\u002FmL and TSAT \\\u003C20%.\n7. Able and willing to perform a CPET at the time of randomization.\n8. Able and willing to provide informed consent.\n\nExclusion Criteria:\n\n1. Hemoglobin \\\u003C9.0 g\u002FdL or Hemoglobin \\>15.0 g\u002FdL.\n2. Renal dialysis or MDRD\u002FCKD-EPI estimated glomerular filtration rate (eGFR) \\\u003C15 ml\u002Fmin\u002F1.73m2.\n3. Body weight \\\u003C35 kg.\n4. Heart failure was secondary to valvular diseases or congenital heart diseases.\n5. History of acquired iron overload; known hemochromatosis or first relatives with hemochromatosis.\n6. Known hypersensitivity to ferric derisomaltose or other IV iron product.\n7. Known active infection (defined as currently treated with oral or intravenous antibiotics), bleeding (gastrointestinal hemorrhagia, menorrhagia, history of peptic ulcer with no evidence of healing or inflammatory bowel disease), malignancy, and hemolytic anemia.\n8. History of chronic liver disease and\u002For alanine transaminase (ALT) or aspartate transaminase (AST) \\>3 times the upper limit of the normal range; myelodysplastic disorder; and known HIV\u002FAIDS disease.\n9. Acute myocardial infarction, acute coronary syndrome, transient ischemic attack, or stroke within 3 months prior to randomization.\n10. Revascularization therapy (coronary artery bypass grafting, percutaneous intervention, or major surgery) within 3 months prior to randomization; or planning cardiac surgery or revascularization.\n11. Already receiving erythropoietin, IV or oral iron therapy, and blood transfusion in previous 30 days prior to randomization.\n12. Use of concurrent immunosuppressive therapy\n13. Any of the following diseases that hinders exercise testing: severe musculoskeletal disease, unstable angina, obstructive cardiomyopathy, severe uncorrected valvular disease, or uncontrolled slow or rapid arrhythmia (mean ventricular rate \\>100 beats\u002Fmin at rest), or uncontrolled hypertension with blood pressure \\>160\u002F100 mm Hg.\n14. Investigator considers a possible alternative diagnosis to account for the patient's HF symptoms: severe obesity, primary pulmonary hypertension, or chronic obstructive pulmonary disease.\n15. Pregnancy or breast feeding.\n16. Participation in another intervention study involving a drug or device within the past 90 days.","ALL","18 Years",{"count":76,"type":77},114,"ESTIMATED","INTERVENTIONAL",[80],"PHASE4","This study will address whether intravenous (IV) iron repletion with a more intensive target will provide greater benefits in improving exercise capacity for patients with chronic heart failure and iron deficiency. One group of participants will receive a high-dose IV iron regimen with a more intensive target, and the other group will receive a low-dose IV iron regimen with a less intensive target.",[83,84],"Heart Failure","Iron Deficiency",[71],"2025-02-15",{"date":88,"type":89},"2025-02-19","ACTUAL",{"date":91,"type":89},"2023-10-01",{"date":93,"type":77},"2026-12-21",{"name":5,"class":6},1]