Readily Available Urinary Sodium Analysis in Patients With Acute Decompensated Heart Failure

NCT ID: NCT06278792

Last Updated: 2024-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-07
• Study Completion Date: 2024-01-05

Brief Summary

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.

Detailed 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.

Conditions

Acute Decompensated Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Standard of Care

48 hour diuretic management at the treating physician's discretion

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: PROCEDURE

Diuretic therapy at the discretion of the physician

Intervention

48-hour nurse-led natriuresis-guided protocol

Group Type: EXPERIMENTAL

Diuretic protocol

Intervention Type: PROCEDURE

Nurse-led natriuresis-guided protocol based on a bedside urinary sodium result

Interventions

Diuretic protocol

Nurse-led natriuresis-guided protocol based on a bedside urinary sodium result

Intervention Type: PROCEDURE

Standard of Care

Diuretic therapy at the discretion of the physician

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fund for Scientific Research, Flanders, Belgium

OTHER

Sponsor Role: collaborator

Ziekenhuis Oost-Limburg

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wilfried Mullens, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Ziekenhuis Oost-Limburg

Locations

Ziekenhuis Oost-Limburg AV

Genk, Limburg, Belgium

Countries

Belgium

Other Identifiers

Z-2021104

Identifier Type: -

Identifier Source: org_study_id