Clinical trial NCT06278792: Readily Available Urinary Sodium Analysis in Patients With Acute Decompensated Heart Failure
Official title: Readily Available Urinary Sodium Analysis in Patients With Acute Decompensated Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Decompensated Heart Failure
Keywords: acute decompensated heart failure
natriuresis
nurse-led
diuretic therapy
Lead sponsor: Ziekenhuis Oost-Limburg
Sponsor class: OTHER
Collaborators: name: Fund for Scientific Research, Flanders, Belgium
First posted: 2024-02-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Urinary sodium excretion after 48 hours
timeFrame: 48 hours
Secondary outcomes:
measure: Urinary output after 48 hours
timeFrame: 48 hours
measure: Urinary sodium excretion on daily base
timeFrame: 24 hours
measure: Urinary output on daily base
timeFrame: 24 hours
measure: Achievement of decongestion
timeFrame: 48 hours
Other outcomes:
measure: Diuretic dose
timeFrame: 48 hours
measure: User-friendliness device and protocol
timeFrame: 180 days
measure: Weight
timeFrame: 48 hours
measure: Number of participants with need for heart failure rehospitalization
timeFrame: 180 days
measure: Rate of all-cause mortality
timeFrame: 180 days
measure: Length of hospital stay
timeFrame: 180 days
measure: Number of participants with severe hypotension
timeFrame: 48 hours
measure: Number of participants with abnormal blood parameters
timeFrame: 3-day follow-up
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg AV
state: Limburg
Study officials:
affiliation: Ziekenhuis Oost-Limburg
name: Wilfried Mullens, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: