Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06714409

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

Led by Oslo University Hospital · Updated on 2024-12-03

180

Participants Needed

1

Research Sites

54 weeks

Total Duration

On this page

Sponsors

O

Oslo University Hospital

Lead Sponsor

U

University of Oslo

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or above
  • Admitted to the ward of Department of Cardiology OUH Ullev�e5l with a clinical diagnosis of acute decompensated heart failure defined by European Society of Cardiology
  • Pro-BNP > 800 ng/l at first day of admission
  • Capable of giving signed informed consent
Not Eligible

You will not qualify if you...

  • Any medical or psychiatric condition which in the opinion of the investigator precludes participation

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Trial Site Locations

Total: 1 location

1

Department of Nephrology, Oslo University Hospital

Oslo, Norway, 0424

Actively Recruiting

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Research Team

B

Bård Waldum-Grevbo, MD, PhD

CONTACT

L

Liv M Jacobsen, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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