Venous Ultrasound Guided Organ Decongestion in Patients Hospitalized with Acute Decompensated Heart Failure
NCT ID: NCT06714409
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
180 participants
INTERVENTIONAL
2024-09-16
2025-10-01
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Intervention arm
Patients in the intervention arm will undergo VExUS examinations at 1st day of inclusion, every other day while hospitalized and at discharge. The results from the VExUS examination (VExUS score) will be provided to the treatment team and the treatment team decides the individual treatment regime based on available information, with the overall goal to optimize decongestionand HF treatment according to current hospital standards. Safety issues and AEs will be assessed.In both gropus echocardiography will be performed at least once during the hospital stay.
VExUS guided decongestion
Treatment team will be provided information about venous organ congestion status.
Standard of care
Patients will undergo VExUS examinations at 1st day of inclusion and at discharge. The results from the VExUS examinations (VExUS score) will NOT be provided to the treatment team. They will be treated and followed up according to standard of care. In both gropus echocardiography will be performed at least once during the hospital stay.
No interventions assigned to this group
Interventions
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VExUS guided decongestion
Treatment team will be provided information about venous organ congestion status.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Oslo
OTHER
Oslo University Hospital
OTHER
Responsible Party
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Bård Waldum-Grevbo
Medical professor, MD, PhD
Locations
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Department of Nephrology, Oslo University Hospital
Oslo, , Norway
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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744207
Identifier Type: -
Identifier Source: org_study_id