RecruitingNot ApplicableNCT06714409

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

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.


Sponsor

Oslo University Hospital

Enrollment

180 participants

Start Date

Sep 16, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether using ultrasound to monitor fluid buildup in veins and organs can help guide diuretic therapy (water pills) in patients hospitalized with acute worsening heart failure. The goal is to remove excess fluid more effectively and improve recovery. **You may be eligible if...** - You are 18 or older - You are admitted to a cardiology ward with a clinical diagnosis of acute decompensated heart failure - Your BNP blood level (a marker of heart stress) is above 800 ng/L on admission - You are able to give informed consent **You may NOT be eligible if...** - You have a medical or psychiatric condition that, in the investigator's opinion, prevents safe participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTVExUS guided decongestion

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


Locations(1)

Department of Nephrology, Oslo University Hospital

Oslo, Norway

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NCT06714409


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