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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Akershus

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Natriuresis-guided escalation of loop diuretics

Treatment groups

270 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Hospital, Akershus

Lead sponsor

Ostfold Hospital Trust

Collaborator