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

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.

Study Overview

• Status: Completed
• Conditions: Acute Decompensated Heart Failure
• Intervention / Treatment: Procedure: Standard of Care; Procedure: Diuretic protocol

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Limburg
    • Genk, Limburg, Belgium, 3600
      • Ziekenhuis Oost-Limburg AV

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care; 48 hour diuretic management at the treating physician's discretion	Procedure: Standard of Care; Diuretic therapy at the discretion of the physician
Experimental: Intervention; 48-hour nurse-led natriuresis-guided protocol	Procedure: Diuretic protocol; Nurse-led natriuresis-guided protocol based on a bedside urinary sodium result

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary sodium excretion after 48 hours	Total natriuresis after 48 hours (mmol)	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary output after 48 hours	Total diuresis after 48 hours (ml)	48 hours
Urinary sodium excretion on daily base	Total natriuresis (mmol) during the first and second 24 h	24 hours
Urinary output on daily base	Total diuresis during the first and second 24 h	24 hours
Achievement of decongestion	Congestion score of no more than trace edema (score < 2) after 48 hours of diuretic treatment. Minimum score 0 (decongested), maximum score 10 (severe congested)	48 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diuretic dose	Dose of loop diuretics and other diuretic agents administered	48 hours
User-friendliness device and protocol	Questionnaire for the nursing staff with regard to user-friendliness of device and diuretic protocol (1 (totally disagree) to 10 (completely agree))	180 days
Weight	Body weight change	48 hours
Number of participants with need for heart failure rehospitalization	Heart failure rehospitalization during the first 180 after start of the study	180 days
Rate of all-cause mortality	All-cause mortality during the first 180 after start of the study	180 days
Length of hospital stay	The time frame between hospital admission and discharge will be calculated	180 days
Number of participants with severe hypotension	systolic blood pressure below 85mmHg	48 hours
Number of participants with abnormal blood parameters	Any abnormal laboratory parameters in the blood (electrolytes, renal function) during a 3 day follow-up will be reported	3-day follow-up

Collaborators and Investigators

• Sponsor: Ziekenhuis Oost-Limburg
• Collaborators: Fund for Scientific Research, Flanders, Belgium
• Investigators: Principal Investigator: Wilfried Mullens, MD PhD, Ziekenhuis Oost-Limburg

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2022
• Primary Completion (Actual): July 12, 2023
• Study Completion (Actual): January 5, 2024

Study Registration Dates

• First Submitted: February 8, 2024
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Estimated): February 26, 2024

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: natriuresis; diuretic therapy; nurse-led; acute decompensated heart failure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Physiological Effects of Drugs; Natriuretic Agents; Diuretics
• Other Study ID Numbers: Z-2021104

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No