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NCT Number: NCT06714409

Venous Ultrasound Guided Organ Decongestion in 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.

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Key information

Conditions

Cardiorenal Syndrome Acute Decompensated Heart Failure Acute Kidney Injury Cardio-Renal Syndrome Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Heart Failure Hyperemia Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VExUS guided decongestion

Diagnostic Test

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

Primary outcomes

  1. Change in VExUS score

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

    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.

Secondary outcomes

  1. Change in NT-ProBNP

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

    Change in biomarker NT-ProBNP in serum.

  2. Change in estimated renal glomerular filtration rate

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

    Estimated glomerular filtration rate (eGFR) is calculated based on serum creatinine, age and gender.

  3. Change in urine albumin creatinine ratio

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

    Urine albumin creatinine is measured in spot urine sample.

  4. Change in symptoms

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

    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.

  5. Length of hospitalization

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

    Number of days from inclusion to discharge from hospital.

  6. Achieved dosage of HF medications at discharge

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

    Current heart failure medication compared to target dose in the national recommendations of HF-patient population.

  7. Safety

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

    Rates of symptomatic hypotension,worsening renal function, arrhythmias, severe metabolic alkalosis and electrolyte disturbances

Study contacts

Contact information is provided by the study sponsor or research team.

Bård Waldum-Grevbo, MD, PhD

CONTACT

[email protected]

+4722119220

Liv M Jacobsen, MD

CONTACT

[email protected]

+4722119199

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • University of Oslo

Registry information

Official study 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.

Acronym: VExOUS-ADHF

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 3, 2024
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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