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NOT YET RECRUITING
NCT07558798
NA

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

Sponsor: University Hospital, Akershus

View on ClinicalTrials.gov

Summary

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 Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

270

Start Date

2026-04

Completion Date

2028-06

Last Updated

2026-04-30

Healthy Volunteers

No

Interventions

OTHER

Natriuresis-guided escalation of loop diuretics

In the intervention arm, intravenous loop diuretics will be administered twice daily, and urinary sodium concentration will be measured two hours after each dose. If urinary sodium is less than 70 mmol/L, the subsequent diuretic dose will be doubled, with additional diuretic agents added if maximum loop diuretic dosing is reached.

Locations (2)

Akershus University Hospital

Lørenskog, Akershus, Norway

Østfold Hospital Trust

Sarpsborg, Østfold fylke, Norway