Vexus Assessment and Natriuresis-guided Diuretic Therapy in Acute Heart Failure
Starting soon · Not applicable
Conditions studied: Venous Congestion, Heart Failure Acute, VExUS, Diuretics
In brief
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.
Key facts
- Study ID
- NCT07558798
- Run by
- University Hospital, Akershus
- People needed
- 270
- Starts
- 2026-04-01
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2026-04-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Akershus University Hospital — Lørenskog, Akershus, Norway
- Østfold Hospital Trust — Sarpsborg, Østfold fylke, Norway
Full record on ClinicalTrials.gov
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