RecruitingRecruiting
Venous Ultrasound Guided Organ Decongestion in Patients Hospitalized with Acute Decompensated Heart Failure
NCT06714409 · Oslo University Hospital
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A Parallel-group, Single-center, Two-arm Treatment Study to Assess the Safety and Effectiveness of Venous Ultrasound Guided Decongestion in Adult Patients Hospitalized with Acute Decompensated Heart Failure.
About this study
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
Inclusion Criteria:
* 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
Exclusion Criteria:
\- Any medical or psychiatric condition which in the opinion of the investigatorprecludes participation
Study design
Enrollment target: 180 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-09-16
Estimated completion: 2025-10-01
Last updated: 2024-12-03
Interventions
Diagnostic Test: VExUS guided decongestion
Primary outcomes
- • Change in VExUS score (From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.)
Sponsor
Oslo University Hospital · other
With: University of Oslo
Contacts & investigators
ContactBård Waldum-Grevbo, MD, PhD · contact · uxwabr@ous-hf.no · +4722119220
ContactLiv M Jacobsen, MD · contact · uxjaiv@ous-hf.no · +4722119199
All locations (1)
Department of Nephrology, Oslo University HospitalRecruiting
Oslo, Norway