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Trial · NCT07469722

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
Primary
Pairwise Comparisons With Wins of Clinical Benefit, a Composite of In-Hospital Mortality, Hospital Length of Stay, Absence of Congestion on DUCS at Discharge, and BNP Reduction From Admission to Day 7 or Discharge.
From randomization until hospital discharge (assessed up to 90 days).
Clinical benefit will be assessed using a hierarchical composite endpoint based on pairwise comparisons (win ratio analysis), including the following components, analyzed in a predefined hierarchical order: 1. In-hospital mortality: death is worse than no death; earlier death is worse than later death; tied if not possible to determine. 2. Hospital length of stay (days): a shorter hospital length of stay is better; a difference of ≥1 day defines a win; tied if the same number of length of stay days. 3. Absence of congestion on DUCS at discharge: \<2 points at discharge on DUCS is better; tied if both have ≥2 points or if both have \<2 points on DUCS. 4. BNP reduction at day 7 or discharge (whichever occurs first): a reduction of ≥30% in BNP is better; tied if both achieve or do not achieve a ≥30% reduction.
SecondaryAll-cause in-hospital mortality.From randomization until hospital discharge (assessed up to 90 days).All-cause mortality occurring between hospital admission and discharge will be analyzed to compare the treatment groups.
SecondaryHospital length of stay.From randomization until hospital discharge (assessed up to 90 days).Hospital length of stay, measured in days, will be compared between treatment groups.
SecondaryProportion of patients without congestion on POCUS at discharge.From randomization until hospital discharge (assessed up to 90 days).Absence of residual congestion at hospital discharge, defined as DUCS \<2 points, will be compared between the intervention group and the standard-of-care group.
SecondaryBNP reduction.From randomization until hospital discharge (assessed up to 90 days).
The proportion of patients achieving a ≥30% reduction in BNP from hospital admission to day 7 or hospital discharge (whichever occurs first) will be compared between the intervention and control groups.
SecondaryChange in body weight.From randomization until hospital discharge (assessed up to 90 days).Change in body weight, measured in kilograms, between hospital admission and discharge will be compared between treatment groups.
SecondaryChange in dyspnea assessed by the Visual Analogue Scale (VAS).Up to day 5.
The area under the curve (AUC) of change in VAS dyspnea score will be compared between treatment groups. Individual scores will be plotted over time, with the x-axis representing study days from baseline to day 5, and the y-axis representing the VAS score (0-100 millimeters). The VAS AUC (millimeter x hour) will be compared between treatment groups.
SecondaryProportion of participants with worsening renal function.Up to day 7.Worsening renal function will be defined as an increase of ≥0.3 mg/dL in serum creatinine or a ≥50% increase from baseline within 7 days.
SecondaryProportion of patients without congestion on EVEREST at discharge.From randomization until hospital discharge (assessed up to 90 days).The proportion of patients with EVEREST composite congestion score (CCS) ≤ 2 points at hospital discharge will be compared between treatment groups.
SecondaryIn-hospital mortality and major in-hospital clinical events.From randomization until hospital discharge (assessed up to 90 days).
A composite outcome including in-hospital mortality, admission to intensive care unit, use of mechanical ventilation, renal replacement therapy, vasopressor use, or inotrope use during the index hospitalization will be assessed and compared between treatment groups.
SecondaryAll-cause mortality or rehospitalization within 30 days.From hospital discharge up to 30 days.The proportion of participants who experience all-cause mortality or rehospitalization within 30 days after hospital discharge will be compared between treatment groups.
SecondaryAll-cause mortality or rehospitalization within 90 days.From hospital discharge up to 90 days.The proportion of participants who experience all-cause mortality or rehospitalization within 90 days after hospital discharge will be compared between treatment groups.
SecondaryProportion of participants with electrolyte abnormalitiesFrom randomization until hospital discharge (assessed up to 90 days).
The proportion of participants with electrolyte abnormalities will be compared between treatment groups, including hypokalemia (serum potassium \< 3.0 mEq/L), hyperkalemia (serum potassium \> 5.5 mEq/L), hyponatremia (serum sodium \< 125 mEq/L), hypernatremia (serum sodium \> 150 mEq/L), hypomagnesemia (serum magnesium \< 1.2 mg/dL), hypermagnesemia (serum magnesium \> 3.0 mg/dL), and metabolic acidosis (serum bicarbonate \< 14 mEq/L with arterial pH \< 7.15).

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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