[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614118":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":18,"locations":24,"responsibleParty":63,"collaborators":66,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":18,"enrollmentInfo":80,"targetDuration":18,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":91,"overallStatus":94,"whyStopped":18,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"University Medical Center Groningen","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Limited number of kidney function assessments","EXPERIMENTAL","Participants in this arm will have standardized kidney function assessments at baseline, three months, and six months. Kidney function assessments in between these moments will be blinded in the electronic patient dossier. Unblinding will be performed if the results are significantly abnormal.",[13],"Other: Blinded kidney function assessments",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","Participants will receive standard care, which includes frequent kidney function assessments.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Blinded kidney function assessments","Kidney function results will be blinded in the intervention group, except at baseline, three months, and six months.",[9],[25,47],{"facility":26,"status":18,"city":27,"state":28,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"Onze Lieve Vrouwe Gasthuis","Amsterdam","North Holland","1090 HM","Netherlands","NL",{"type":33,"coordinates":34},"Point",[35,36],4.88969,52.37403,{"lat":36,"lon":35},[39,44],{"name":40,"role":41,"phone":42,"phoneExt":18,"email":43},"Dr. P.E.J. van Pol, MD","CONTACT","+31 (0)20 599 91 11","p.e.j.vanpol@olvg.nl",{"name":45,"role":46,"phone":18,"phoneExt":18,"email":18},"Petra E.J. van Pol, MD","PRINCIPAL_INVESTIGATOR",{"facility":48,"status":18,"city":49,"state":50,"zip":51,"country":30,"countryCode":31,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"Frisius MC","Leeuwarden","Provincie Friesland","8934 AD",{"type":33,"coordinates":53},[54,55],5.80973,53.20271,{"lat":55,"lon":54},[58,61],{"name":59,"role":41,"phone":42,"phoneExt":18,"email":60},"Dr. C. da Fonseca MD","carlos.da.fonseca@mcl.nl",{"name":62,"role":46,"phone":18,"phoneExt":18,"email":18},"Carlos da Fonseca, MD",{"type":46,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Jozine ter Maaten","Assistant prof. J.M. ter Maaten, MD, PhD",[67,68],{"name":26,"class":6},{"name":69,"class":6},"Frisius Medisch Centrum","100614118","effectiveness-and-safety-of-uptitration-of-guideline-directed-medical-therapy-in-heart-failure-with-reduced-ejection-fraction-with-limited-kidney-function-assessments-100614118",false,"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","ALL","18 Years",{"count":81,"type":82},344,"ESTIMATED","INTERVENTIONAL",[85],"NA","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.",[88,89,90],"Heart Failure","Heart Failure and Reduced Ejection Fraction","Heart Failure and Mildly Reduced Ejection Fraction",[92,93],"Guideline-Directed Medical Therapy","Limited Kidney Function Assessments","NOT_YET_RECRUITING","2025-12-10",{"date":97,"type":98},"2025-12-18","ACTUAL",{"date":100,"type":82},"2026-04-01",{"date":102,"type":82},"2030-01-01",{"name":5,"class":6},2]