Venous Ultrasound Guided Organ Decongestion in Patients Hospitalized with Acute Decompensated Heart Failure (VExOUS-ADHF)

University of Oslo (UIO)

Status: Enrolling

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

Treatments: Diagnostic Test: VExUS guided decongestion

Study type: Interventional

Funder types: Other

Identifiers

NCT06714409

744207

Details and patient eligibility

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Intervention arm

Experimental group

Description:

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.

Treatment:

Diagnostic Test: VExUS guided decongestion

Standard of care

No Intervention group

Description:

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.