[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100537097":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":40,"locations":31,"responsibleParty":47,"collaborators":31,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":31,"enrollmentInfo":58,"targetDuration":31,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":71,"whyStopped":31,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":31},{"fullName":5,"class":6},"Clinica Alemana de Santiago","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Furosemide alone","ACTIVE_COMPARATOR","Active comparator arm with intravenous furosemide dosing based on glomerular filtration rate (protocol).",[13],"Drug: Furosemide Injection",{"label":15,"type":16,"description":17,"interventionNames":18},"Acetazolamide plus Furosemide","EXPERIMENTAL","Experimental arm number 1 corresponds to oral acetazolamide 250mg (once daily) in combination with furosemide according to the protocol.",[19,13],"Drug: Acetazolamide 250 MG",{"label":21,"type":16,"description":22,"interventionNames":23},"Metolazone plus Furosemide","Experimental arm number 2 corresponds to oral metolazone 2.5mg (once daily) in combination with furosemide according to the protocol.",[24,13],"Drug: Metolazone 2.5 MG",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Acetazolamide 250 MG","Acetazolamide 250mg orally per day plus furosemide as per protocol. The intervention is administered on the day of hospital admission and for two consecutive mornings. The total intervention consists of 3 doses. The intervention is discontinued on the third morning. The calculation of the congestion score is performed every morning until the third morning. If complete decongestion is achieved, the primary outcome will be considered fulfilled.",[15],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Metolazone 2.5 MG","Metolazone 2.5mg orally per day plus furosemide as per protocol. The intervention is administered on the day of hospital admission and for two consecutive mornings. The total intervention consists of 3 doses. The intervention is discontinued on the third morning. The calculation of the congestion score is performed every morning until the third morning. If complete decongestion is achieved, the primary outcome will be considered fulfilled.",[21],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Furosemide Injection","Intravenous furosemide in a double daily dose. The dosage is determined by a predefined table based on the admission renal function and the outpatient dose prior to admission. In general terms, for patients with an estimated glomerular filtration rate above 60 ml\u002Fmin\u002F1.73m² or those experiencing heart failure debut, the dose will be 1x the outpatient dose. For those with a glomerular filtration rate below 60 ml\u002Fmin\u002F1.73m², the dose will be 2x the outpatient dose. The dosing protocol for this arm also serves as guidance for furosemide in the intervention arms.",[15,9,21],[41],{"name":42,"role":43,"phone":44,"phoneExt":45,"email":46},"Franco Appiani, MD","CONTACT","222101111","+56","fappiani@alemana.cl",{"type":48,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100537097","acetazolamide-or-metolazone-in-acute-heart-failure-100537097",false,"NCT06273397","Acetazolamide or Metolazone in Acute Heart Failure","ACME-AHF","Inclusion Criteria:\n\n* Acute heart failure: Hospitalization due to symptoms of heart failure, congestion signs documented with a congestion score greater than 1, NT-proBNP above 1000 pg\u002Fml.\n* Randomization within 24 hours of admission.\n\nExclusion Criteria:\n\n* Under 18 years of age.\n* Received more than one dose of intravenous furosemide before randomization.\n* Cause of heart failure: hypertrophic or restrictive cardiomyopathy, or constrictive pericarditis.\n* Acute coronary syndrome or severe acute valvulopathy as the cause of decompensation.\n* Systolic blood pressure \\\u003C 90mmHg before randomization.\n* Requirement for vasopressors, inotropes, or invasive mechanical ventilation. Use of intravenous vasodilators or non-invasive mechanical ventilation is allowed.\n* Glomerular filtration rate \\\u003C 20ml\u002Fmin\u002F1.73m2.\n* Potassium \\\u003C 2.5 mEQ\u002FL or Sodium \\\u003C 125 mEQ\u002FL before randomization.\n* pH \\\u003C 7.2 or Bicarbonate \\\u003C 15mEQ\u002FL before randomization.\n* Use of another diuretic in addition to furosemide before randomization. Dapagliflozin or Empagliflozin can be maintained upon admission or initiated early during hospitalization if desired by the treating physician (variable to be recorded).\n* Patients who cannot achieve adequate recording of variables (e.g., inability to quantify diuresis or weight).\n* Pregnant or lactating individuals. If of childbearing age and there is inconsistency with contraceptive use or reasonable doubts about current pregnancy, a pregnancy test must be conducted before study entry.","ALL","18 Years",{"count":59,"type":60},1050,"ESTIMATED","INTERVENTIONAL",[63],"NA","Impact of Acute Heart Failure:\n\nAccording to the World Health Organization (WHO), approximately 26 million people suffer from Heart Failure (HF), with a mortality rate of up to 50% within five years of diagnosis. Acute Heart Failure (AHF) exacerbations, leading to hospitalization, are common and represent the primary cause of hospital admissions in those over 65. Effective decongestion during hospitalization is crucial, as failure to achieve it doubles the risk of rehospitalization and mortality, incurring significant healthcare costs.\n\nUse of Diuretics in Acute Heart Failure:\n\nDiuretics, particularly loop diuretics like furosemide, are a cornerstone in managing AHF by inducing natriuresis and achieving decongestion. Clinical experience supports their use, though limited clinical trials exist. Pharmacological concepts guide their administration, emphasizing intravenous delivery in high doses and adjusting subsequent doses based on decongestive efficacy. Additionally, sequential tubular blockade with other diuretics like metolazone and acetazolamide is explored to enhance decongestion.\n\nUse of Metolazone and Acetazolamide:\n\nSequential tubular blockade, using metolazone and acetazolamide in conjunction with furosemide, aims to achieve rapid and effective decongestion. While metolazone targets the distal tubule, inhibiting sodium-chloride channels, acetazolamide affects proximal tubular function. Studies like ADVOR (acetazolamide) and CLOROTIC (thiazide-like diuretic) demonstrate the potential benefits of combining these diuretics for quicker decongestion but with potential risks (in the case of Hydrochlorothiazide).\n\nOutcomes Measured by Major Studies:\n\nRecent studies assessing decongestion in AHF reveal a lack of uniformity in outcome selection. The primary focus should be on reducing rehospitalizations and post-discharge mortality by achieving effective decongestion. The ADVOR study, using a simple congestion score based on clinical and imaging criteria, underscores the importance of reaching a congestion score of 0 or 1 promptly.\n\nCongestion Monitoring:\n\nMonitoring diuretic treatment solely based on clinical aspects may not capture subclinical congestion, necessitating biochemical and imaging parameters. The ACME-AHF trial proposes a diagnostic score integrating clinical and imaging aspects to evaluate congestion status. Secondary outcomes include cumulative diuresis, weight loss, diuretic efficiency, and natriuresis, with a focus on natriuresis as a reliable physiological parameter for decongestion.\n\nAim of the study:\n\nThe ACME-AHF trial is designed to compare the efficacy and safety of two diuretic combination strategies: acetazolamide with furosemide and metolazone with furosemide. The primary objective is to relieve congestion, assessed using a congestion score, within the first three days of treatment during an hospitalization for acute heart failure.",[66,67],"Heart Failure Acute","Decompensated Heart Failure",[69,70,66],"Acetazolamide","Metolazone","NOT_YET_RECRUITING","2024-03-14",{"date":74,"type":75},"2024-03-18","ACTUAL",{"date":77,"type":60},"2024-05-01",{"date":79,"type":60},"2027-05-01",{"name":5,"class":6}]