[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643108":3},{"organization":4,"outcomesModule":7,"designInfo":49,"detailedDescription":54,"studyPopulation":54,"armGroups":58,"interventions":79,"overallOfficials":90,"centralContacts":54,"locations":107,"responsibleParty":124,"collaborators":128,"id":130,"slug":131,"hasResults":132,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":132,"sex":138,"minAge":139,"maxAge":54,"enrollmentInfo":140,"targetDuration":54,"studyType":143,"phases":144,"briefSummary":146,"conditions":147,"keywords":151,"overallStatus":159,"whyStopped":54,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":169},{"fullName":5,"class":6},"West Kazakhstan Marat Ospanov Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":38},[9],{"measure":10,"description":11,"timeFrame":12},"Hierarchical Composite Endpoint of Unsuccessful Decongestion","1. Escalation of heart failure therapy within the first 5 days of hospitalization.\n2. Persistent clinical congestion at hospital discharge, defined as the presence of at least two of the following: dyspnea at rest, orthopnea, pulmonary rales, peripheral edema, or elevated jugular venous pressure.\n3. Failure to transition from intravenous to oral loop diuretics by Day 5 of hospitalization.\n4. Residual ultrasound congestion at hospital discharge, defined as ≥1 zone with ≥3 B-lines (one positive zone) on each hemithorax using 8-zone scanning","From randomization through hospital discharge, assessed up to 14 days.",[14,18,22,26,30,34],{"measure":15,"description":16,"timeFrame":17},"Total and Time-Specific Urinary Sodium Excretion","Urinary sodium excretion measured at 6, 24, 48, and 72 hours after initiation of intravenous loop diuretic therapy.","6, 24, 48, and 72 hours after initiation of intravenous loop diuretic therapy.",{"measure":19,"description":20,"timeFrame":21},"Time to Clinical Decongestion","Time from initiation of intravenous loop diuretic therapy to achievement of clinical decongestion, defined as resolution of clinical signs and symptoms of congestion, including absence of dyspnea at rest, orthopnea, pulmonary rales, peripheral edema, and elevated jugular venous pressure.","From initiation of intravenous loop diuretic therapy until clinical decongestion, assessed up to 14 days.",{"measure":23,"description":24,"timeFrame":25},"Length of Hospital Stay","Duration of hospitalization measured as the number of days from hospital admission to hospital discharge.","From hospital admission to hospital discharge, assessed up to 30 days.",{"measure":27,"description":28,"timeFrame":29},"Death or Heart Failure Rehospitalization Within 30 Days After Discharge","Composite outcome of all-cause mortality or rehospitalization due to worsening heart failure occurring within 30 days after hospital discharge.","From hospital discharge through 30 days after discharge.",{"measure":31,"description":32,"timeFrame":33},"Cumulative Urine Output","Total urine output measured during hospitalization.","From initiation of intravenous loop diuretic therapy through hospital discharge, assessed up to 14 days.",{"measure":35,"description":36,"timeFrame":37},"Proportion of Patients Achieving Predefined Natriuresis Targets","Proportion of patients achieving predefined urinary sodium excretion targets according to the study treatment algorithm during the first 72 hours of hospitalization.","Within 72 hours after initiation of intravenous loop diuretic therapy.",[39,42,46],{"measure":40,"description":41,"timeFrame":12},"Incidence of Symptomatic Hypotension","Occurrence of symptomatic hypotension during hospitalization.",{"measure":43,"description":44,"timeFrame":45},"Clinically Significant Electrolyte Disturbances","Occurrence of clinically significant abnormalities in serum potassium or sodium during hospitalization.","From baseline through hospital discharge, assessed up to 14 days.",{"measure":47,"description":48,"timeFrame":12},"All-Cause In-Hospital Mortality","Death from any cause occurring during hospitalization.",{"allocation":50,"interventionModel":51,"interventionModelDescription":52,"primaryPurpose":53,"observationalModel":54,"timePerspective":54,"maskingInfo":55},"RANDOMIZED","PARALLEL","Participants will be randomized in a parallel-group design to receive either standard urine output-guided therapy or natriuresis-guided decongestive therapy using one of the predefined intravenous furosemide administration regimens. Treatment will be delivered according to the assigned study arm throughout the index hospitalization.","TREATMENT",null,{"masking":56,"maskingDescription":57,"whoMasked":54},"NONE","Due to the nature of the intervention, the study is conducted in an open-label design. Urinary sodium measurements in the standard-of-care group will remain concealed from treating physicians and will not be used for protocol-driven treatment adjustment. Whenever feasible, investigators responsible for outcome assessment and statistical analysis will remain blinded to treatment allocation.",[59,65,71,75],{"label":60,"type":61,"description":62,"interventionNames":63},"Standard Treatment","ACTIVE_COMPARATOR","Standard urine output-guided decongestive therapy according to institutional practice and predefined treatment protocols.",[64],"Drug: Furosemide",{"label":66,"type":67,"description":68,"interventionNames":69},"Natriuresis-Guided Intermittent IV Bolus","EXPERIMENTAL","Natriuresis-guided decongestive therapy using intermittent intravenous bolus administration of furosemide with dose titration based on urinary sodium assessment.",[64,70],"Device: Horiba LAQUAtwin B-722",{"label":72,"type":67,"description":73,"interventionNames":74},"Natriuresis-Guided Continuous Infusion","Natriuresis-guided decongestive therapy using continuous intravenous furosemide infusion via infusion pump with dose titration based on urinary sodium assessment.",[64,70],{"label":76,"type":67,"description":77,"interventionNames":78},"Natriuresis-Guided Prolonged Intermittent Infusion","Natriuresis-guided decongestive therapy using prolonged intermittent intravenous furosemide infusion with dose titration based on urinary sodium assessment.",[64,70],[80,85],{"type":81,"name":82,"description":83,"armGroupLabels":84,"otherNames":54},"DRUG","Furosemide","Intravenous loop diuretic therapy administered according to predefined treatment algorithms, including intermittent bolus administration, continuous infusion, or prolonged intermittent infusion with protocol-driven dose titration.",[72,66,76,60],{"type":86,"name":87,"description":88,"armGroupLabels":89,"otherNames":54},"DEVICE","Horiba LAQUAtwin B-722","Portable point-of-care urinary sodium analyzer used for serial spot urinary sodium measurements to guide decongestive therapy.",[72,66,76],[91,94,97,100,103,105],{"name":92,"affiliation":5,"role":93},"Nurgul Ablakimova, PhD","PRINCIPAL_INVESTIGATOR",{"name":95,"affiliation":5,"role":96},"Vadim Medovchshikov, PhD","STUDY_DIRECTOR",{"name":98,"affiliation":99,"role":93},"Anzhela Soloveva, candidate of medical sciences","I.M. Sechenov First Moscow State Medical University",{"name":101,"affiliation":99,"role":102},"Svetlana Rachina, doctor of medical sciences","STUDY_CHAIR",{"name":104,"affiliation":5,"role":102},"Gaziza Smagulova, candidate of medical sciences",{"name":106,"affiliation":5,"role":93},"Ayagoz Meshitbayeva",[108],{"facility":5,"status":54,"city":109,"state":54,"zip":110,"country":111,"countryCode":112,"cosmosGeoPoint":113,"geoPoint":118,"contacts":119},"Aktobe","030000","Kazakhstan","KZ",{"type":114,"coordinates":115},"Point",[116,117],57.20718,50.27969,{"lat":117,"lon":116},[120],{"name":106,"role":121,"phone":122,"phoneExt":54,"email":123},"CONTACT","77714040296","ayagozmeshitbayeva@gmail.com",{"type":125,"investigatorFullName":126,"investigatorTitle":127,"investigatorAffiliation":5,"oldNameTitle":54,"oldOrganization":54},"SPONSOR_INVESTIGATOR","Nurgul Ablakimova","Dr",[129],{"name":99,"class":6},"100643108","sure-hf-urinary-sodium-guided-diuretic-therapy-in-heart-failure-100643108",false,"NCT07631780","SURE-HF: Urinary Sodium-Guided Diuretic Therapy in Heart Failure","Urinary Sodium-Guided Optimization of Diuretic Therapy in Patients With Worsening Heart Failure: Rationale and Design of a Pragmatic Randomized Controlled Trial (SURE-HF Trial)","SURE-HF","Inclusion Criteria:\n\n* Age ≥18 years.\n* Confirmed diagnosis of worsening heart failure (WHF), characterized by symptoms and signs of acute decompensation requiring hospitalization for intensification of intravenous diuretic therapy.\n* Previous intake of a loop diuretic (torasemide or furosemide) in any dose for at least 2 days before hospitalization.\n* Presence of clinical signs and symptoms of congestion (e.g., dyspnea, orthopnea, peripheral edema, pulmonary congestion).\n* Provision of written informed consent.\n\nExclusion Criteria:\n\n* Acute coronary syndrome within the previous 30 days.\n* Acute heart failure requiring urgent invasive intervention, including cardiogenic shock or mechanical circulatory support.\n* Current admission to an intensive care unit.\n* Systolic blood pressure ≤90 mmHg or requirement for inotropic\u002Fvasopressor support.\n* Recent use (≤48 hours) of inotropic agents affecting fluid and electrolyte balance.\n* Estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m² or requirement for renal replacement therapy.\n* Hypokalemia (\\\u003C3.5 mmol\u002FL) or hyperkalemia (≥5.5 mmol\u002FL).\n* Clinically significant hyponatremia (\\\u003C130 mmol\u002FL) or hypernatremia (\\>150 mmol\u002FL).\n* Significant comorbidities affecting sodium-water balance (e.g., liver cirrhosis with ascites, nephrotic syndrome, severe infection or sepsis).\n* Pregnancy or breastfeeding.\n* Active malignancy.\n* Inability to comply with the study protocol or participation in another interventional clinical trial.","ALL","18 Years",{"count":141,"type":142},260,"ESTIMATED","INTERVENTIONAL",[145],"NA","The SURE-HF trial is a pragmatic, multicentre, randomized controlled study evaluating natriuresis-guided optimization of intravenous loop diuretic therapy in patients hospitalized with worsening heart failure (WHF). The study aims to determine whether serial urinary sodium assessment combined with a structured decongestive treatment algorithm improves decongestion, reduces the need for therapy escalation, and enhances discharge readiness compared with standard care.\n\nParticipants will be randomized to standard urine output-guided therapy or natriuresis-guided decongestive strategies using different intravenous loop diuretic administration regimens. The study integrates bedside diagnostic tools including lung ultrasound, inferior vena cava assessment, focused echocardiography, and serial clinical congestion monitoring.\n\nThe primary endpoint is a hierarchical composite outcome including escalation of heart failure therapy, persistent congestion at discharge, inability to transition to oral loop diuretics by Day 5, and residual ultrasound congestion. The findings of the SURE-HF trial may support implementation of urinary sodium-guided and ultrasound-assisted decongestive therapy in routine heart failure management.",[148,149,150],"Worsening Heart Failure","Congestion","Heart Failure",[148,149,152,153,154,155,156,157,158],"Natriuresis","Urinary Sodium","Diuretic Therapy","Loop Diuretics","Decongestion","Fluid Overload","Bedside Diagnostics","NOT_YET_RECRUITING","2026-06-01",{"date":162,"type":163},"2026-06-08","ACTUAL",{"date":165,"type":142},"2026-06",{"date":167,"type":142},"2027-12",{"name":126,"class":6},1]