[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100460483":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":39,"centralContacts":44,"locations":53,"responsibleParty":114,"collaborators":117,"id":125,"slug":126,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":127,"sex":133,"minAge":134,"maxAge":30,"enrollmentInfo":135,"targetDuration":30,"studyType":138,"phases":139,"briefSummary":141,"conditions":142,"keywords":146,"overallStatus":56,"whyStopped":30,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Furosemide only","ACTIVE_COMPARATOR","• Boluses of 40 mg furosemide given as soon as possible and repeated up to 10 times by the discretion of the treating physician.",[13],"Drug: Furosemide Injection",{"label":15,"type":10,"description":16,"interventionNames":17},"isosorbide dinitrate","• Boluses of 3 mg IV isosorbide dinitrate given as soon as possible and repeated up to 10 times by the discretion of the treating physician.",[18],"Drug: Isosorbide Dinitrate",{"label":20,"type":10,"description":21,"interventionNames":22},"isosorbide dinitrate + furosemide","• Boluses of both 3 mg IV isosorbide dinitrate + of 40 mg furosemide given as soon as possible and repeated up to 10 times by the discretion of the treating physician.",[23],"Drug: Furosemide and isosorbide dinitrate",[25,31,35],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Furosemide Injection","A diuretic (iv furosemide) strategy for decongestion in acute heart failure",[9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Isosorbide Dinitrate","Vasodilation (iv isosorbide dinitrate) strategy for decongestion in acute heart failure",[15],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Furosemide and isosorbide dinitrate","Vasodilation (iv isosorbide dinitrate) strategy for decongestion in acute heart failure AND A diuretic (iv furosemide) strategy for decongestion in acute heart failure",[20],[40],{"name":41,"affiliation":42,"role":43},"Johannes Grand, PhD","Hvidovre University Hospital","PRINCIPAL_INVESTIGATOR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":30,"email":49},"Johannes Grand, MD, Phd, MPH","CONTACT","+4535452121","johannes.grand@regionh.dk",{"name":51,"role":47,"phone":30,"phoneExt":30,"email":52},"Jens Jakob Thune, MD, PhD","jens.jakob.thune@regionh.dk",[54,72,84,99],{"facility":55,"status":56,"city":57,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Bispebjerg Hospital","RECRUITING","Copenhagen","2000","Denmark","DK",{"type":62,"coordinates":63},"Point",[64,65],12.56553,55.67594,{"lat":65,"lon":64},[68,69],{"name":51,"role":47,"phone":30,"phoneExt":30,"email":52},{"name":70,"role":71,"phone":30,"phoneExt":30,"email":30},"Jens Jakob Thune","SUB_INVESTIGATOR",{"facility":73,"status":56,"city":57,"state":57,"zip":74,"country":59,"countryCode":60,"cosmosGeoPoint":75,"geoPoint":77,"contacts":78},"Hvidovre Hospital","2650",{"type":62,"coordinates":76},[64,65],{"lat":65,"lon":64},[79,83],{"name":80,"role":47,"phone":81,"phoneExt":82,"email":49},"Johannes Grand, MD, PhD","35452121","+45",{"name":80,"role":43,"phone":30,"phoneExt":30,"email":30},{"facility":85,"status":56,"city":86,"state":30,"zip":30,"country":59,"countryCode":60,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Nordsjællands Hospital","Hillerød",{"type":62,"coordinates":88},[89,90],12.30081,55.92791,{"lat":90,"lon":89},[93,97],{"name":94,"role":47,"phone":95,"phoneExt":82,"email":96},"Søren Junge, MD","48295298","soeren.junge.nielsen@regionh.dk",{"name":98,"role":43,"phone":30,"phoneExt":30,"email":30},"Søren Junge, MD, PhD",{"facility":100,"status":101,"city":102,"state":30,"zip":30,"country":59,"countryCode":60,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Roskilde Hospital","NOT_YET_RECRUITING","Roskilde",{"type":62,"coordinates":104},[105,106],12.08035,55.64152,{"lat":106,"lon":105},[109,112],{"name":110,"role":47,"phone":30,"phoneExt":30,"email":111},"Matias Lindholm","matiasgl@dadlnet.dk",{"name":113,"role":43,"phone":30,"phoneExt":30,"email":30},"Matias Lindholm, MD, PhD",{"type":43,"investigatorFullName":115,"investigatorTitle":116,"investigatorAffiliation":42,"oldNameTitle":30,"oldOrganization":30},"Johannes Grand","Principal investigator",[118,120,122,123],{"name":119,"class":6},"Zealand University Hospital",{"name":121,"class":6},"Copenhagen University Hospital, Hvidovre",{"name":55,"class":6},{"name":124,"class":6},"Herlev Hospital","100460483","phase-4-optimized-treatment-of-pulmonary-edema-or-congestion-100460483",false,"NCT05276219","Optimized Treatment of Pulmonary Edema or Congestion","Vasodilation or Loop-diuretics for Initial Treatment of Pulmonary Edema or Congestion Due to Acute Heart Failure - a Randomized Placebo-controlled Trial","Decongest","Inclusion criteria\n\n1. Age ≥ 18 years\n2. Acute (within minutes to days) onset or worsening of subjective dyspnea\\*\n3. Systolic blood pressure ≥100 mmHg\n4. Oxygen saturation \\\u003C94% or need of oxygen\n5. Signs or suspicion of congestion (peripheral edema, rales, and\u002For clinical suspicion of congestion) \\*\n\n   * by the best assessment from a medical doctor. Inclusion must not wait on x-ray or other measures: patients suspected of pulmonary congestion should be included immediately.\n\nExclusion criteria\n\n1. More than 40 mg IV furosemide within the last three hours before randomization including prehospital treatment.\n2. More than 3 hours from hospital-admission to randomization\n3. Ongoing ventricular taky- or brady-arrythmias or supraventricular arrhythmias with HR \\> 180 or \\\u003C 40 bpm.\n4. Suspected severe infection or sepsis.\n\nExclusion criteria are purposely liberal, so patients can be included in accordance with everyday clinical practice. However, a safety criterion will be implemented:\n\nIf blood pressure drops below 90 mmHg in 2 measurements with 5 minutes apart and\u002For if urine production is below 50 ml after 1 hour, the intervention will be stopped, and patients can receive furosemide and nitrates freely.\n\nWe purposely chose not to exclude patients with aortic stenosis, since observational studies did not find excess risk of given nitrates to patients with pulmonary edema and aortic stenosis","ALL","18 Years",{"count":136,"type":137},1104,"ESTIMATED","INTERVENTIONAL",[140],"PHASE4","Background:\n\nIntravenous (IV) loop-diuretics have been a key component in treating pulmonary edema since the nineteen sixties and has a Class 1 recommendation in the 2021 European Society of Cardiology guidelines for heart failure. Conversely, vasodilation was downgraded in the treatment of acute heart failure due to a lack of trials that compare vasodilation with loop-diuretics in a hyperacute clinical setting. This clinical equipoise will be tested in a trial including patients with pulmonary congestion immediately at hospital admission.\n\nPrimary objective:\n\nTo determine the superior strategy of loop-diuretics (furosemide), vasodilation (nitrates) or the combination during emergency treatment.\n\nDesign: Investigator-initiated, randomized, double-blinded, placebo-controlled trial with 1:1:1 allocation.\n\nIntervention:\n\nIntervention-phase will last 6 hours from study-inclusion, and patients will be allocated to one of three groups:\n\n* Boluses of 40 mg IV furosemide + nitrate-placebo as soon as possible and repeated up to 10 times.\n* Boluses of 3 mg IV isosorbide dinitrate + furosemide-placebo as soon as possible.\n* Boluses of both 3 mg IV isosorbide dinitrate + of 40 mg as soon as possible.",[143,144,145],"Pulmonary Edema","Congestive Heart Failure","Acute Heart Failure",[147,148],"acute heart failure","Pulmonary edema","2026-04-17",{"date":151,"type":152},"2026-04-22","ACTUAL",{"date":154,"type":152},"2023-09-14",{"date":156,"type":137},"2027-05-31",{"name":5,"class":6},4]