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
Sponsors and collaborators
University Hospital, Akershus
Lead sponsor
Ostfold Hospital Trust
Collaborator