Readily Available Urinary Sodium Analysis in Patients With Acute Decompensated Heart Failure (EASY-HF)

East Limburg Hospital

Status: Completed

Conditions: Acute Decompensated Heart Failure

Treatments: Procedure: Diuretic protocol; Procedure: Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT06278792

Z-2021104

Details and patient eligibility

About

The goal of this clinical trial is to compare physician-guided (SOC) versus nurse-led natriuresis-guided diuretic therapy in patients with acute decompensated heart failure (ADHF). The main questions it aims to answer are:

• difference in natriuresis and diuresis
• feasibility of the protocol.

Participants will be asked to gather two 24 h urine collections.

Researchers will compare SOC versus nurse-led diuretic titration to see if there is a difference in natriuresis after 48 hours.

Full description

The EASY-HF study was a single-centre, randomized, open-label study comparing standard of care (SOC) diuretic management at the treating physician's discretion with a nurse-led natriuresis-guided protocol in patients with ADHF. A bedside sensor was used to measure the urinary sodium content.The primary endpoint was total natriuresis after 48 hours. Secondary endpoints included safety profile and user-friendliness of both the protocol and the point-of-care sensor.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Older than 18 years
• Provide written informed consent
• Hospital admission with signs and symptoms of congestion warranting intravenous decongestive therapy
• Congestion score of at least 2 based upon the presence of edema, pleural effusion, or ascites
• N-terminal pro-B-type natriuretic peptide (NT-proBNP) level of at least 500 ng per litre (800 ng per litre in case of atrial fibrillation)

Exclusion criteria

• Patients unable to collect a 48h-urine collection
• Estimated GFR below 20 ml/min/1.73m^2
• Concomitant diagnosis of an acute coronary syndrome
• Need for inotropic or vasopressor support
• Ventricular assist device
• Renal replacement therapy
• Treatment with intravenous loop diuretics > 80mg furosemide or an equivalence of another loop diuretic (40mg furosemide = 1mg bumetanide) during the index hospitalization and prior to randomization

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Standard of Care

Active Comparator group

Description:

48 hour diuretic management at the treating physician's discretion

Treatment:

Procedure: Standard of Care

Intervention

Experimental group

Description:

48-hour nurse-led natriuresis-guided protocol

Treatment:

Procedure: Diuretic protocol