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Metolazone 2.5 MG / Acetazolamide / Acute Heart Failure · Phase 4 Trial
ClinicalTrials.gov · August 14, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 4 double-blind, randomized, controlled trial registered to enroll approximately 939 adults hospitalized with acute heart failure and volume overload. The study compares loop-diuretics combined with metolazone or acetazolamide against loop-diuretics alone, with days alive out-of-hospital by day 30 as the primary outcome. Results are not yet reported in this registry record.
Phase 4, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Acute Heart Failure; age from 18 Years. Intervention: Acetazolamide; Metolazone. Compared with: Placebo — Placebo Comparator. n = 939. 5 sites: Denmark.
This is a Phase 4 double-blind, randomized, controlled trial registered to enroll approximately 939 adults hospitalized with acute heart failure and volume overload. The study compares loop-diuretics combined with metolazone or acetazolamide against loop-diuretics alone, with days alive out-of-hospital by day 30 as the primary outcome. Results are not yet reported in this registry record.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
This is a clinical trial registry record describing a planned Phase 4 interventional study with no results yet reported; it documents study design and enrollment targets only.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06166654). This is a study registration, not published results. Lead sponsor: Johannes Grand. Recruitment status: RECRUITING. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 939 participants (ESTIMATED). Conditions: Acute Heart Failure. Interventions: DRUG: Acetazolamide; DRUG: Metolazone 2.5 MG; OTHER: Double-placebo. Primary outcome measures: Days alive out-of-hospital to day 30 , 30 days. Brief summary: 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. Eligible 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. The 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. The 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.
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