[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"heart-failure-and-mildly-reduced-ejection-fraction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:heart-failure-and-mildly-reduced-ejection-fraction":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,78],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":33,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100634736","phase-3-selenium-intervention-registry-randomized-trial-in-heart-failure-100634736",false,"NCT07543562","Selenium Intervention Registry Randomized Trial in Heart Failure","SIRI-HF","Inclusion Criteria:\n\nTo be considered for inclusion in this study, patients must meet all of the following eligibility requirements:\n\n* 18 years of age\n* primary discharge diagnosis of HF coded as ICD-10: I50, as recorded in The SwedeHF registry\n* be able to provide documented informed consent by signing and dating the designated consent form.\n\nExclusion Criteria:\n\n* Not suitable in the opinion of the Investigator (for example due to severe or terminal comorbidity with poor prognosis, or characteristics, pregnancy etc.) that may interfere with adherence to trial protocol","ALL","18 Years",{"count":19,"type":20},4326,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","Heart failure is a serious condition in which the heart is unable to pump blood effectively, and it remains a leading cause of hospitalization and death worldwide despite advances in treatment.\n\nSelenium is an essential micronutrient that plays an important role in cellular energy production, antioxidant defense, and overall cardiovascular function. Low selenium levels are common among patients with heart failure in Northern Europe, and observational studies have shown that selenium deficiency is associated with an increased risk of hospitalization and death. In cases of severe deficiency, such as in Keshan disease, heart dysfunction can be reversed with selenium supplementation, suggesting a potential causal relationship.\n\nHowever, it is not yet known whether selenium supplementation can improve clinical outcomes in patients with heart failure when added to standard medical therapy.\n\nThe SIRI-HF trial is a randomized, placebo-controlled study designed to evaluate whether daily supplementation with 200 micrograms of selenium, in addition to guideline-directed medical therapy, improves outcomes in patients with heart failure.\n\nThe primary endpoint is a composite of recurrent heart failure hospitalizations and cardiovascular death. Secondary endpoints include all-cause mortality, changes in symptoms and functional status, and safety outcomes.\n\nThis study will include patients from Sweden and Norway and aims to determine whether correcting selenium deficiency can improve prognosis in heart failure.",[26,27,28,29,30,31,32],"Heart Failure","Heart Failure and Reduced Ejection Fraction","Heart Failure and Mildly Reduced Ejection Fraction","Heart Failure and Preserved Ejection Fraction","Selenium Supplementation","Selenium","Cognitive Functioning",[34,35,36,14],"heart failure","selenium","RRCT","RECRUITING","2026-04-15",{"date":40,"type":41},"2026-04-22","ACTUAL",{"date":43,"type":41},"2026-04-01",{"date":45,"type":20},"2031-03",{"name":47,"class":48},"Skane University Hospital","OTHER",11,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100628901","infusing-needed-iron-to-target-insufficiency-in-adults-treated-for-evidence-of-heart-failure-100628901","NCT07467668","Infusing Needed Iron to Target Insufficiency in Adults Treated for Evidence of Heart Failure","INITIATE-HF","Inclusion Criteria:\n\nAdults (age \\>18 years); Diagnosed heart failure with most recent left ventricular ejection fraction \\\u003C50%; Hospitalized for any reason for the index admission; Documented iron deficiency defined as TSAT \\\u003C20% during the index hospitalization; At least 6 months of health plan coverage and prescription drug benefit before admission\n\nExclusion Criteria:\n\nA documented allergy to IV iron in the Kaiser Permanente Northern California (KPNC) electronic health record (EHR) system; A history of hemochromatosis (i.e., iron overload) based on KPNC EHR data; End-stage kidney disease (defined as receiving chronic dialysis or a prior kidney transplant) or advanced chronic kidney disease (i.e., estimated glomerular filtration rate \\[eGFR\\] \\\u003C30 mL\u002Fmin\u002F1.73 m2) based on most recent pre-admission outpatient laboratory results or the KPNC regional End-Stage Kidney Disease Treatment Registry; Serum ferritin \\>300 ng\u002FmL based on KPNC EHR data; Diagnosed with metastatic cancer and\u002For receiving systemic chemotherapy based on KPNC EHR data; Institutionalized (e.g., prison) and\u002For receiving palliative care per KPNC EHR data",{"count":58,"type":20},3000,[60],"NA","The INITIATE-HF study is a cluster randomized controlled trial that aims to find out if reminding doctors about treatment guidelines for iron deficiency in adults with heart failure who are hospitalized and have evidence of iron deficiency changes the subsequent use of intravenous (IV) iron.\n\nTwo groups of hospitalized adult patients with known heart failure and iron deficiency will be compared:\n\n* Group 1 will include doctors who receive a notification with their patient's iron storage test results and guideline recommendations related to the use of IV iron.\n* Group 2 will include doctors who do not receive this notification and continue with usual standard of care.\n\nThe study will measure if this provider-facing notification affects physician use of recommended IV iron treatment in eligible patients with heart failure, left ventricular ejection fraction less than 50%, and iron deficiency. Secondarily, if there is an increased use of IV iron observed in the intervention group, this study will evaluate whether there are differential health outcomes (i.e., fewer subsequent hospital visits and lower risk of death) of patients whose providers were assigned to the intervention group.",[63,26,27,28],"Iron Deficiency (ID)",[65,66,34],"IV iron","iron deficiency","NOT_YET_RECRUITING","2026-03-11",{"date":70,"type":41},"2026-03-12",{"date":72,"type":20},"2026-03-09",{"date":74,"type":20},"2028-12-31",{"name":76,"class":48},"Kaiser Permanente",1,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":21,"phases":88,"briefSummary":89,"conditions":90,"keywords":91,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},"100614118","effectiveness-and-safety-of-uptitration-of-guideline-directed-medical-therapy-in-heart-failure-with-reduced-ejection-fraction-with-limited-kidney-function-assessments-100614118","NCT07275437","Effectiveness and Safety of Uptitration of Guideline Directed MEdical Therapy in Heart Failure With Reduced Ejection Fraction With Limited Kidney Function Assessments","A Randomized, Controlled Trial Investigating the Effectiveness and Safety of Uptitration of Guideline Directed MEdical Therapy in Heart Failure With a Reduced Ejection Fraction With Limited Standardized Kidney Function Assessments (RESUME-HF-Kidney)","RESUME-HF","Inclusion Criteria:\n\n1. Able and willing to give written informed consent\n2. Age ≥ 18 years\n3. Diagnosed with HFrEF (LVEF≤ 45%) according to criteria from 2021 European Society of Cardiology guidelines for heart failure\n4. Less than 100% target dose of 2 individual reno-active GDMT classes (ACEi\u002FARB\u002FARNI, MRA or SGLT-2i)\n\nExclusion Criteria:\n\n1. eGFR\\\u003C25 mL\u002Fmin\u002F1.73 m2 measured up to 30 days before the first visit\n2. Potassium \\> 5.5 mmol\u002FL or \\\u003C3.5 mmol\u002FL at screening\n3. Known intolerance or allergy to two individual GDMT\n4. Signs of hemodynamic instability and\u002For cardiogenic shock\n5. Decompensated heart failure requiring treatment with intravenous loop diuretics\n6. Known concomitant structural kidney disease such as polycystic kidney disease or renal artery stenosis",{"count":87,"type":20},344,[60],"Guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF) constitutes of four medications that substantially reduce morbidity and mortality, and improve quality of life. In routine clinical practice, various physician- and patient-related factors lead to suboptimal initiation and uptitration of GDMT to optimal dosing, which is associated with worse patient outcomes. A perceived major barrier to the optimalization of GDMT are changes in kidney function and electrolytes, which prompts physicians to halt uptitration, reduce doses, or even discontinue GDMT. Changes in kidney function and electrolytes during optimalization of GDMT are common, but not associated with adverse events.\n\nThe hypothesis of this study is that a reduction in the number of kidney function assessments during initiation and uptitration of GDMT in HFrEF patients will lead to higher achieved doses of GDMT without safety concerns.",[26,27,28],[92,93],"Guideline-Directed Medical Therapy","Limited Kidney Function Assessments","2025-12-10",{"date":96,"type":41},"2025-12-18",{"date":43,"type":20},{"date":99,"type":20},"2030-01-01",{"name":101,"class":48},"University Medical Center Groningen",2]