Venous Ultrasound Guided Organ Decongestion in Patients Hospitalized with Acute Decompensated Heart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOslo University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years of age or above
Admitted the ward of Department of Cardiology OUH Ullevål with a clinical diagnosis of ADHFdefined by European Society of Cardiology
Pro-BNP > 800 ng/l at first day of admission
Capable of giving signed informed consent
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
VExUS guided decongestion
Diagnostic testTreatment team will be provided information about venous organ congestion status.
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: Intervention armExperimental treatment 1 intervention
Group B: Standard of careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change 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.Secondary outcomes
1
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.2
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.3
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.4
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Oslo University Hospital
Lead sponsor
University of Oslo
Collaborator
Source ClinicalTrials.gov