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

ConditionsVenous Congestion Heart Failure Acute VExUS Diuretics

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Natriuresis-guided escalation of loop diuretics
Other intervention
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.

Treatment groups

270 Participants

are divided into 2 treatment groups

Group A: Natriuresis-guided decongestionExperimental treatment 1 intervention

Group B: Treatment as usualNo intervention 0 interventions

Trial outcomes

Primary outcomes

Win Ratio in patients with VExUS score 3

Win Ratio of hierarchical composite endpoint (90-day all-cause mortality, 90-day all-cause rehospitalization, and index hospitalization length of stay) comparing natriuresis-guided diuretic therapy versus standard of care in patients with acute heart failure and severe venous congestion (VExUS score 3) at hospital admission.

Time frame

90 days

Secondary outcomes

Key Secondary Endpoint 1: Difference in win ratio between patients with VExUS grade 3 versus VExUS grade 0-2

Interaction analysis assessing whether the win ratio of the primary composite endpoint (90-day mortality, 90-day rehospitalization, and hospital length of stay) for natriuresis-guided diuretic therapy versus standard of care differs between patients with VExUS grade 3 and patients with VExUS grade 0-2 at hospital admission. Tested only if the primary endpoint is statistically significant.

Time frame

90 days

Key Secondary Endpoint 2: Win ratio in patients with VExUS grade 0-2

Hierarchical composite win ratio of 90-day mortality, 90-day rehospitalization, and hospital length of stay for natriuresis-guided diuretic therapy versus standard of care, assessed in patients with VExUS grade 0-2 at hospital admission. Tested only if Key Secondary Endpoint 1 is statistically significant.

Time frame

90 days

Other outcomes

90-day time-to-mortality

Difference in survival stratified by VExUS score and intervention group

Time frame

90 days

90-day time-to-hospitalization

Difference in hospitalization stratified by VExUS score and intervention group

Time frame

90 days

Hospital length-of-stay

Comparison of hospital length-of-stay between different VExUS score groups and intervention groups

Time frame

90 days

In-hospital mortality

Assessed as time-to-mortality from date and time of admission measured in hours.

Time frame

From date and time of hospital admission to in-hospital death, censored at time of discharge, assessed up to 30 days

Sponsors and contacts

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University Hospital, Akershus

Lead sponsor

Ostfold Hospital Trust

Collaborator

Source ClinicalTrials.gov

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