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Adjusting water pill doses by urine sodium in acute heart failure

Tests urine sodium-guided water pill dosing in adults hospitalized with acute heart failure.

Plain-language title generated from the registry record
Registry title: Vexus Assessment and Natriuresis-guided Diuretic Therapy in Acute Heart Failure

Key facts

Where
Lørenskog and Sarpsborg, NorwaySee the 2 sites

Where in Norway

  • Akershus University HospitalLørenskog, NorwayNo longer taking part
  • Østfold Hospital TrustSarpsborg, NorwayNo longer taking part

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Trial details

Who runs it
University Hospital, Akershus
Trial code
NCT07558798
Record updated
30 April 2026
Original description
This study evaluates whether natriuresis-guided diuretic therapy improves outcomes in patients with acute heart failure (AHF) and severe congestion. All patients hospitalized with AHF will be screened using Venous Excess Ultrasound (VExUS) and randomized 1:1 to either natriuresis-guided escalation of loop diuretics or standard care. The primary endpoint, evaluated in patients with VExUS grade 3 (severe congestion), is a hierarchical composite (win ratio) of 90-day mortality, 90-day rehospitalization, and hospital length of stay. Key secondary endpoints (hierarchical) include (1) difference in win ratio between patients with VExUS 3 versus VExUS 0-2 at hospital admission (assessed by interaction testing and statistically tested only if the primary endpoint is significant) and (2) win ratio (primary endpoint) tested among patients with VExUS 0-2 at hospital admission (statistically tested only if the first key seconday endpoint is significant). Exploratory endpoints include in-hospital clinical, hemodynamic, and biochemical outcomes (mortality, eGFR, NT-proBNP, NYHA class, VExUS score, natriuresis/diuresis, and patient-reported dyspnea), associations between congestion markers (VExUS, FibroScan, lung ultrasound, clinical score, and NT-proBNP), as well as quality of life at 90 days, GDMT optimization score at discharge, and long-term time to readmission and mortality assessed through registry linkage.Read full original descriptionShow less

Vexus Assessment and Natriuresis-guided Diuretic Therapy in Acute Heart Failure

This study evaluates whether natriuresis-guided diuretic therapy improves outcomes in patients with acute heart failure (AHF) and severe congestion. All patients hospitalized with AHF will be screened using Venous Excess Ultrasound (VExUS) and randomized 1:1 to either natriuresis-guided escalation of loop diuretics or standard care. The primary endpoint, evaluated in patients with VExUS grade 3 (severe congestion), is a hierarchical composite (win ratio) of 90-day mortality, 90-day rehospitalization, and hospital length of stay. Key secondary endpoints (hierarchical) include (1) difference in win ratio between patients with VExUS 3 versus VExUS 0-2 at hospital admission (assessed by interaction testing and statistically tested only if the primary endpoint is significant) and (2) win ratio (primary endpoint) tested among patients with VExUS 0-2 at hospital admission (statistically tested only if the first key seconday endpoint is significant). Exploratory endpoints include in-hospital clinical, hemodynamic, and biochemical outcomes (mortality, eGFR, NT-proBNP, NYHA class, VExUS score, natriuresis/diuresis, and patient-reported dyspnea), associations between congestion markers (VExUS, FibroScan, lung ultrasound, clinical score, and NT-proBNP), as well as quality of life at 90 days, GDMT optimization score at discharge, and long-term time to readmission and mortality assessed through registry linkage.

Inclusion: Age >18 years; Hospitalization with AHF, either de novo or worsening of chronic HF; Able to provide written informed consent; Requirement of intravenous loop diuretic treatment as judged by the treating physician.

Exclusion: Dyspnea primarily due to non-cardiac causes; Advanced renal disease or estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73m2 at screening or on-going dialysis; Enrollment in another study interfering with the treatment algorithm of the current study; Inability to follow the treatment protocol; Language barriers requiring the need for an external interpreter; Pregnant or nursing (lactating) women; Very short life expectancy (<30 days).

ClinicalTrials.gov NCT07558798