Clinical trial NCT06714409: Venous Ultrasound Guided Organ Decongestion in Patients Hospitalized with Acute Decompensated Heart Failure
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiorenal Syndrome
Heart Failure
Acute Kidney Injury
Acute Decompensated Heart Failure
Keywords: Cardiorenal syndrome
Acute kidney injury
Heart failure
VExUS
Venous congestion
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2024-12-03
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single centre, parallel group, randomized controlled trail. Approximately 250 participants will be screened to achieve 90 randomly enrolled to study intervention and 90 participants to SOC arm for an estimated total of 180 evaluable participants.
Primary purpose: DIAGNOSTIC

Brief summary: 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

Primary outcomes:
measure: Change in VExUS score
timeFrame: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
Secondary outcomes:
measure: Change in NT-ProBNP
timeFrame: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
measure: Change in estimated renal glomerular filtration rate
timeFrame: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
measure: Change in urine albumin creatinine ratio
timeFrame: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
measure: Change in symptoms
timeFrame: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
measure: Length of hospitalization
timeFrame: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
measure: Achieved dosage of HF medications at discharge
timeFrame: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
measure: Safety
timeFrame: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Department of Nephrology, Oslo University Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.