Venous Ultrasound Guided Organ Decongestion in Patients Hospitalized with Acute Decompensated Heart Failure

NCT06714409 | Recruiting

• 1 other identifier: 744207
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiorenal Syndrome; Heart Failure; Acute Kidney Injury; Acute Decompensated Heart Failure

Keywords

Cardiorenal syndrome; Acute kidney injury; Heart failure; VExUS; Venous congestion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in NT-ProBNP

  From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.

• Change in estimated renal glomerular filtration rate

  From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.

• Change in urine albumin creatinine ratio

  From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.

• Change in symptoms

  From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.

• Length of hospitalization

  From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.

Study Arms (2)

Intervention arm

EXPERIMENTAL

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

Standard of care

NO INTERVENTION

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.

Interventions

VExUS guided decongestion DIAGNOSTIC_TEST

Treatment team will be provided information about venous organ congestion status.

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Any medical or psychiatric condition which in the opinion of the investigatorprecludes participation

Sponsors & Collaborators

• Oslo University Hospital: lead
• University of Oslo: collaborator

Study Sites (1)

Department of Nephrology, Oslo University Hospital

Oslo, 0424, Norway

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Cardio-Renal Syndrome; Heart Failure; Acute Kidney Injury; Hyperemia

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

Bård Waldum-Grevbo, MD, PhD

CONTACT

+4722119220; uxwabr@ous-hf.no

Liv M Jacobsen, MD

CONTACT

+4722119199; uxjaiv@ous-hf.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical professor, MD, PhD

Model Details: 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.

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: December 3, 2024
• Study Start: September 16, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)