Venous Ultrasound Guided Organ Decongestion in Patients Hospitalized with Acute Decompensated Heart Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VExUS guided decongestion.
- Who it may be relevant to
- Registry conditions: Cardiorenal Syndrome, Heart Failure, Acute Kidney Injury, Acute Decompensated Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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.
Interventions
- Diagnostic test VExUS guided decongestion
Treatment team will be provided information about venous organ congestion status.
Primary outcome measures
- Change in VExUS score [Time frame: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.]
Secondary outcome measures (7)
- Change in NT-ProBNP [Time frame: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.]
- Change in estimated renal glomerular filtration rate [Time frame: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.]
- Change in urine albumin creatinine ratio [Time frame: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.]
- Change in symptoms [Time frame: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.]
- Length of hospitalization [Time frame: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.]
- Achieved dosage of HF medications at discharge [Time frame: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.]
- Safety [Time frame: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Norway · 1 center
- Department of Nephrology, Oslo University Hospital — Oslo
Publications
- Longino A, Martin K, Leyba K, Siegel G, Thai TN, Riscinti M, Douglas IS, Gill E, Burke J. Prospective Evaluation of Venous Excess Ultrasound for Estimation of Venous Congestion. Chest. 2024 Mar;165(3):590-600. doi: 10.1016/j.chest.2023.09.029. Epub 2023 Oct 7. PMID 37813180
- Damman K, van Deursen VM, Navis G, Voors AA, van Veldhuisen DJ, Hillege HL. Increased central venous pressure is associated with impaired renal function and mortality in a broad spectrum of patients with cardiovascular disease. J Am Coll Cardiol. 2009 Feb 17;53(7):582-588. doi: 10.1016/j.jacc.2008.08.080. PMID 19215832
- Mullens W, Abrahams Z, Francis GS, Sokos G, Taylor DO, Starling RC, Young JB, Tang WHW. Importance of venous congestion for worsening of renal function in advanced decompensated heart failure. J Am Coll Cardiol. 2009 Feb 17;53(7):589-596. doi: 10.1016/j.jacc.2008.05.068. PMID 19215833
- Beaubien-Souligny W, Rola P, Haycock K, Bouchard J, Lamarche Y, Spiegel R, Denault AY. Quantifying systemic congestion with Point-Of-Care ultrasound: development of the venous excess ultrasound grading system. Ultrasound J. 2020 Apr 9;12(1):16. doi: 10.1186/s13089-020-00163-w. PMID 32270297
Identifiers
NCT: NCT06714409 · 744207