[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100528890":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":41,"centralContacts":46,"locations":53,"responsibleParty":100,"collaborators":40,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":106,"sex":112,"minAge":113,"maxAge":40,"enrollmentInfo":114,"targetDuration":40,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":55,"whyStopped":40,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"Copenhagen University Hospital, Hvidovre","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Acetazolamide","ACTIVE_COMPARATOR","1\\. 500 mg IV bolus of acetazolamide at randomization (day 0) and repeated the next 3 mornings (day 1, day 2 and day 3). This arm will also receive a placebo- Metolazone tablet together with each acetazolamide-injection.",[13],"Drug: Acetazolamide",{"label":15,"type":10,"description":16,"interventionNames":17},"Metolazone","2.5 mg oral Metolazone at randomization (day 0) and repeated the next 3 mornings (day 1, day 2 and day 3). This arm will also receive a placebo- acetazolamide injection together with each metolazone-tablet.",[18],"Drug: Metolazone 2.5 MG",{"label":20,"type":21,"description":22,"interventionNames":23},"Placebo","PLACEBO_COMPARATOR","Usual care with loop-diuretics as the sole diuretic (SGLT2-inhibitors allowed) including guideline-recommended increase in loop-diuretic dose and fluid and salt-restriction. This arm will also receive both a placebo-acetazolamide injection together with a placebo-metolazone-tablet at randomization and repeated the next 3 mornings (day 1, day 2 and day 3).",[24],"Other: Double-placebo",[26,31,36],{"type":27,"name":9,"description":11,"armGroupLabels":28,"otherNames":29},"DRUG",[9],[30],"Standard of care including loop-diuretics",{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Metolazone 2.5 MG","2\\. 2.5 mg oral Metolazone at randomization (day 0) and repeated the next 3 mornings (day 1, day 2 and day 3). This arm will also receive a placebo- acetazolamide injection together with each metolazone-tablet.",[15],[30],{"type":6,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Double-placebo","This arm will also receive both a placebo-acetazolamide injection together with a placebo-metolazone-tablet at randomization and repeated the next 3 mornings (day 1, day 2 and day 3).",[20],null,[42],{"name":43,"affiliation":44,"role":45},"Johannes Grand, MD, Phd, MPH","Amager-Hvidovre Hospital","PRINCIPAL_INVESTIGATOR",[47,51],{"name":43,"role":48,"phone":49,"phoneExt":40,"email":50},"CONTACT","+4535452121","johannes.grand@regionh.dk",{"name":52,"role":48,"phone":40,"phoneExt":40,"email":40},"Sandra Tonning, MD",[54,72,89],{"facility":44,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"RECRUITING","Hvidovre","Capital Region of Denmark","2650","Denmark","DK",{"type":62,"coordinates":63},"Point",[64,65],12.47708,55.64297,{"lat":65,"lon":64},[68,70],{"name":69,"role":48,"phone":49,"phoneExt":40,"email":50},"Johannes Grand, MD, PhD, MPH",{"name":71,"role":45,"phone":40,"phoneExt":40,"email":40},"Johannes Grand, MD, PhD",{"facility":73,"status":74,"city":75,"state":40,"zip":76,"country":59,"countryCode":60,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Bispebjerg Hospital","NOT_YET_RECRUITING","Copenhagen","2400",{"type":62,"coordinates":78},[79,80],12.56553,55.67594,{"lat":80,"lon":79},[83,88],{"name":84,"role":48,"phone":85,"phoneExt":86,"email":87},"Jens Jakob Thune, MD, PhD","38683767","+45","jens.jakob.thune@regionh.dk",{"name":84,"role":45,"phone":40,"phoneExt":40,"email":40},{"facility":90,"status":55,"city":75,"state":40,"zip":91,"country":59,"countryCode":60,"cosmosGeoPoint":92,"geoPoint":94,"contacts":95},"Herlev-Gentofte hospital","2730",{"type":62,"coordinates":93},[79,80],{"lat":80,"lon":79},[96,99],{"name":97,"role":48,"phone":40,"phoneExt":40,"email":98},"Morten Schou, MD, PhD","morten.schou.04@regionh.dk",{"name":97,"role":45,"phone":40,"phoneExt":40,"email":40},{"type":101,"investigatorFullName":102,"investigatorTitle":103,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"SPONSOR_INVESTIGATOR","Johannes Grand","Principal Investigator","100528890","phase-4-optimal-diuretic-therapies-for-acute-heart-failure-with-volume-overload-100528890",false,"NCT06166654","Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload","Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload - A Randomized Clinical Trial","DRAIN-AHF","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Acute hospital admission with a clinical diagnosis of acute heart failure with volume overload.\n3. Display risk of diuretic resistance, characterized by:\n\n   1. Daily loop-diuretics administration for a minimum of 7 days before admission, or\n   2. Insufficient decongestion observed in the preceding 24 hours (weight reduction \\\u003C500g or negative fluid balance \\\u003C1L) despite being treated with high-dose IV loop diuretic (equivalent to ≥120 mg IV furosemide within 24 hours).\n4. Clinical signs of congestion, indicated by one or more of the following: pitting peripheral edema, ascites, elevated jugular venous pressure, or radiological\u002Fultrasonic evidence of pulmonary congestion.\n\nExclusion Criteria:\n\n1. Acute coronary syndrome\n2. Systolic blood pressure \\\u003C85 mmHg\n3. Use of renal replacement therapy or ultrafiltration in-hospital before study inclusion\n4. Treatment with acetazolamide or metolazone during the index hospitalization prior to randomization\n5. Known allergy to any of the used drugs\n6. Severe hypokalemia (\\\u003C2.5 mmol\u002Fl) or severe hyponatremia (\\\u003C125 mmol\u002Fl)\n7. Severe hepatic impairment or liver cirrhosis\n8. Known pregnancy","ALL","18 Years",{"count":115,"type":116},939,"ESTIMATED","INTERVENTIONAL",[119],"PHASE4","Aim to identify the best strategy for treating acute heart failure (AHF) with volume overload, particularly focusing on patients resistant to standard loop-diuretics. The trial is a double-blinded, randomized, controlled, multicenter study. Its primary objective is to compare the efficacy of loop-diuretics combined with either Metolazone or Acetazolamide, against loop-diuretics alone. The trial will also determine the optimal type of loop-diuretic to use.\n\nEligible participants include adults over 18 years hospitalized with AHF and volume overload, showing signs of congestion and at risk of diuretic resistance. Exclusions apply to those with acute coronary syndrome, low systolic blood pressure, prior renal therapy, or previous treatment with Acetazolamide or Metolazone.\n\nThe primary outcome is the number of days alive and out-of-hospital by day 30. Secondary outcomes include a composite clinical benefit at 30 days, Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, and successful decongestion 72 hours post-inclusion.\n\nThe trial aims to enroll about 1,041,939 patients across three treatment arms over three years. The minimal important difference is set as a reduction in out-of-hospital days by at least two days, with an anticipated low dropout rate. The study's power is calculated to be 80% with an adjusted alpha level for comparing the three diuretic groups.",[122],"Acute Heart Failure",[124,125,126],"acute heart failure","decongestion","diuretic","2025-02-19",{"date":129,"type":130},"2025-02-20","ACTUAL",{"date":132,"type":130},"2024-09-05",{"date":134,"type":116},"2027-09-30",{"name":102,"class":6},3]