The purpose of this study is to assess the feasibility, safety and effectiveness of VExUS guided organ decongestion compared to standard of care in patients hospitalized with acute decompensated heart failue (ADHF). 180 patients will be randomly assigned to either intervention (VExUS) arm or standard of care (SOC) arm. In the intervention arm, the treatment team will be informed by the study team about the results of the VExUS examination to supplement the clinical decision of proper decongestion treatment, while no information will be provided in the standard of care arm. Study visits are scheduled every second day while hospitalized, end of study is set to day of discharge from the ward. Telephone consultation and review of medical journal scheduled after 6 months to assess exploratory endpoints. The overall rationale of the the study is to investigate if venous organ congestion investigated by VExUS score, is a modifiable risk factor in patients hospitalized with ADHF. And secondary to assess if venous organ decongestion guided by VExUS score may safely be implemented in patients hospitalized with ADHF and result in: * differences in length of hospitalization * changes in biomarkers of cardiac strain * changes in renal function and markers of renal injury * achieved doses of heart failure treatment at discharge * in-hospital complications Safety measures with special attention on symptomatic hypotension, arrhythmias, metabolic alkalosis and electrolyte disturbances will be addressed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
180
Treatment team will be provided information about venous organ congestion status.
Department of Nephrology, Oslo University Hospital
Oslo, Norway
RECRUITINGChange in VExUS score
The findings from Doppler ultrasonography of the hepatic vein, portal vein, and interlobar renal vein will be graded using the VExUS score, which reflects the degree of venous congestion. The scale ranges from 0 to 3, where a score of 0 indicates no signs of congestion, 1 indicates mild congestion, 2 indicates moderate congestion, and 3 indicates severe congestion.
Time frame: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
Change in NT-ProBNP
Change in biomarker NT-ProBNP in serum.
Time frame: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
Change in estimated renal glomerular filtration rate
Estimated glomerular filtration rate (eGFR) is calculated based on serum creatinine, age and gender.
Time frame: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
Change in urine albumin creatinine ratio
Urine albumin creatinine is measured in spot urine sample.
Time frame: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
Change in symptoms
Participants are asked to grade their symptoms using a 7-point Likert scale ranging from 1 to 7, where 1 indicates markedly better, 4 indicates no change, and 7 indicates markedly worse. Additionally, participants are asked to report their general condition and level of dyspnea on a Visual Analogue Scale (VAS) where 0 is negative and 100 is positive.
Time frame: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
Length of hospitalization
Number of days from inclusion to discharge from hospital.
Time frame: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
Achieved dosage of HF medications at discharge
Current heart failure medication compared to target dose in the national recommendations of HF-patient population.
Time frame: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
Safety
Rates of symptomatic hypotension,worsening renal function, arrhythmias, severe metabolic alkalosis and electrolyte disturbances
Time frame: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
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