NCT06278792

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 8, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 26, 2024

Completed
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

1.3 years

First QC Date

February 8, 2024

Last Update Submit

February 19, 2024

Conditions

Acute Decompensated Heart Failure

Keywords

acute decompensated heart failurenatriuresisnurse-leddiuretic therapy

Outcome Measures

Primary Outcomes (1)

  • Urinary sodium excretion after 48 hours

    Total natriuresis after 48 hours (mmol)

    48 hours

Secondary Outcomes (4)

  • Urinary output after 48 hours

    48 hours

  • Urinary sodium excretion on daily base

    24 hours

  • Urinary output on daily base

    24 hours

  • Achievement of decongestion

    48 hours

Other Outcomes (8)

  • Diuretic dose

    48 hours

  • User-friendliness device and protocol

    180 days

  • Weight

    48 hours

  • +5 more other outcomes

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

48 hour diuretic management at the treating physician's discretion

Procedure: Standard of Care

Intervention

EXPERIMENTAL

48-hour nurse-led natriuresis-guided protocol

Procedure: Diuretic protocol

Interventions

Diuretic protocolPROCEDURE

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

Intervention
Standard of CarePROCEDURE

Diuretic therapy at the discretion of the physician

Standard of Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziekenhuis Oost-Limburg AV

Genk, Limburg, 3600, Belgium

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Wilfried Mullens, MD PhD

    Ziekenhuis Oost-Limburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
All physicians were blinded for the spot urinary sodium measurements. Additionally, while urine was collected for the first 48 h in both groups, the analysis was only performed afterwards.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2024

First Posted

February 26, 2024

Study Start

March 7, 2022

Primary Completion

July 12, 2023

Study Completion

January 5, 2024

Last Updated

February 26, 2024

Record last verified: 2024-02

Locations

BE(1)