Venous Ultrasound Guided Organ Decongestion in Patients Hospitalized with Acute Decompensated Heart Failure (VExOUS-ADHF)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Acute Decompensated Heart Failure; Acute Kidney Injury; Cardiorenal Syndrome
• Intervention / Treatment: Diagnostic test: VExUS guided decongestion

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bård Waldum-Grevbo, MD, PhD; Phone Number: +4722119220; Email: uxwabr@ous-hf.no
• Study Contact Backup: Name: Liv M Jacobsen, MD; Phone Number: +4722119199; Email: uxjaiv@ous-hf.no

Study Locations

• Norway
  • Oslo, Norway, 0424
    • Recruiting
    • Department of Nephrology, Oslo University Hospital
    • Contact: Bård Waldum-Grevbo, MD, PhD; Phone Number: +4722119220; Email: uxwabr@ous-hf.no
    • Contact: Liv M Jacobsen, MD; Phone Number: +4722119199; Email: uxjaiv@ous-hf.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Diagnostic test: VExUS guided decongestion; Treatment team will be provided information about venous organ congestion status.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in NT-ProBNP	Change in biomarker NT-ProBNP in serum.	From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
Change in estimated renal glomerular filtration rate	Estimated glomerular filtration rate (eGFR) is calculated based on serum creatinine, age and gender.	From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
Change in urine albumin creatinine ratio	Urine albumin creatinine is measured in spot urine sample.	From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
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.	From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
Length of hospitalization	Number of days from inclusion to discharge from hospital.	From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
Achieved dosage of HF medications at discharge	Current heart failure medication compared to target dose in the national recommendations of HF-patient population.	From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
Safety	Rates of symptomatic hypotension,worsening renal function, arrhythmias, severe metabolic alkalosis and electrolyte disturbances	From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: University of Oslo

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: November 21, 2024
• First Submitted That Met QC Criteria: November 28, 2024
• First Posted (Actual): December 3, 2024

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 28, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Heart failure; Acute kidney injury; Cardiorenal syndrome; Venous congestion; VExUS
• Additional Relevant MeSH Terms: Urogenital Diseases; Cardiovascular Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Heart Diseases; Renal Insufficiency; Heart Failure; Acute Kidney Injury; Cardio-Renal Syndrome
• Other Study ID Numbers: 744207

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No