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

Not Applicable

Recruiting

• Conditions: Cardiorenal Syndrome; Heart Failure; Acute Kidney Injury; Acute Decompensated Heart Failure

• Registration Number: NCT06714409
• Lead Sponsor: Oslo University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-16
• Status Verified: 2024-11
• Study First Submitted: 2024-11-21
• Study First Submitted QC: 2024-11-28
• Last Update Submitted: 2024-11-28
• Study First Posted: 2024-12-03
• Last Update Posted: 2024-12-03
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in VExUS score	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 Outcome Measures

Name	Time	Method
Change in NT-ProBNP	From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.	Change in biomarker NT-ProBNP in serum.
Change in estimated renal glomerular filtration rate	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.
Change in urine albumin creatinine ratio	From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.	Urine albumin creatinine is measured in spot urine sample.
Change in symptoms	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.
Length of hospitalization	From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.	Number of days from inclusion to discharge from hospital.
Achieved dosage of HF medications at discharge	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.
Safety	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

Trial Locations

Locations (1)

Department of Nephrology, Oslo University Hospital; 🇳🇴 Oslo, Norway