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Completed

NCT Number: NCT06278792

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuis Oost-Limburg AV

Genk, Limburg, 3600, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diuretic protocol

Procedure

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

Standard of care

Procedure

Diuretic therapy at the discretion of the physician

Primary outcomes

  1. Urinary sodium excretion after 48 hours

    Time frame: 48 hours

    Total natriuresis after 48 hours (mmol)

Secondary outcomes

  1. Urinary output after 48 hours

    Time frame: 48 hours

    Total diuresis after 48 hours (ml)

  2. Urinary sodium excretion on daily base

    Time frame: 24 hours

    Total natriuresis (mmol) during the first and second 24 h

  3. Urinary output on daily base

    Time frame: 24 hours

    Total diuresis during the first and second 24 h

  4. Achievement of decongestion

    Time frame: 48 hours

    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)

Other outcomes

  1. Diuretic dose

    Time frame: 48 hours

    Dose of loop diuretics and other diuretic agents administered

  2. User-friendliness device and protocol

    Time frame: 180 days

    Questionnaire for the nursing staff with regard to user-friendliness of device and diuretic protocol (1 (totally disagree) to 10 (completely agree))

  3. Weight

    Time frame: 48 hours

    Body weight change

  4. Number of participants with need for heart failure rehospitalization

    Time frame: 180 days

    Heart failure rehospitalization during the first 180 after start of the study

  5. Rate of all-cause mortality

    Time frame: 180 days

    All-cause mortality during the first 180 after start of the study

  6. Length of hospital stay

    Time frame: 180 days

    The time frame between hospital admission and discharge will be calculated

  7. Number of participants with severe hypotension

    Time frame: 48 hours

    systolic blood pressure below 85mmHg

  8. Number of participants with abnormal blood parameters

    Time frame: 3-day follow-up

    Any abnormal laboratory parameters in the blood (electrolytes, renal function) during a 3 day follow-up will be reported

Sponsors and collaborators

Lead sponsor

Ziekenhuis Oost-Limburg

Other

Collaborators

  • Fund for Scientific Research, Flanders, Belgium

Registry information

Acronym: EASY-HF

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Feb 26, 2024
Registry last updated
Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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