Acute Decompensated Heart FailureEASY-HFNCT06278792
Readily Available Urinary Sodium Analysis in Patients With Acute Decompensated Heart Failure
A study testing Diuretic protocol in people with Acute Decompensated Heart Failure, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Decompensated Heart Failure
- What is being tested?
- Diuretic protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 7 Mar 2022to 5 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Diuretic protocol, Standard of Care
- Keywords
- acute decompensated heart failure, natriuresis, nurse-led, diuretic therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diuretic protocolProcedure or surgery
Nurse-led natriuresis-guided protocol based on a bedside urinary sodium result
Standard of CareProcedure or surgery
Diuretic therapy at the discretion of the physician
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | 48 hour diuretic management at the treating physician's discretion Receives: Procedure: Standard of Care |
| Intervention | Experimental | 48-hour nurse-led natriuresis-guided protocol Receives: Procedure: Diuretic protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary sodium excretion after 48 hours
Total natriuresis after 48 hours (mmol)
Measured: 48 hours
Secondary outcomes (4)
Urinary output after 48 hours
Total diuresis after 48 hours (ml)
Measured: 48 hours
Urinary sodium excretion on daily base
Total natriuresis (mmol) during the first and second 24 h
Measured: 24 hours
Urinary output on daily base
Total diuresis during the first and second 24 h
Measured: 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)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start7 Mar 2022
- Primary completion12 Jul 2023
- Study completion5 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Decompensated Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Responsible party
- Sponsor
- Investigators
- Wilfried Mullens, MD PhD, Principal investigator, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278792
- Sponsor's protocol ID
- Z-2021104
- Acronym
- EASY-HF
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Readily Available Urinary Sodium Analysis in Patients With Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT06278792
- Acronym / sponsor ID
- EASY-HF / Z-2021104
- Conditions
- Acute Decompensated Heart Failure
- Keywords
- acute decompensated heart failure, natriuresis, nurse-led, diuretic therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 12 Jul 2023 (actual)
- Study completion
- 5 Jan 2024 (actual)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Procedure: Standard of Care48 hour diuretic management at the treating physician's discretion |
| Intervention | Experimental | Procedure: Diuretic protocol48-hour nurse-led natriuresis-guided protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diuretic protocolNurse-led natriuresis-guided protocol based on a bedside urinary sodium result | Procedure or surgery | Intervention |
| Standard of CareDiuretic therapy at the discretion of the physician | Procedure or surgery | Standard of Care |
Primary outcome
Urinary sodium excretion after 48 hours
Time frame: 48 hours
Total natriuresis after 48 hours (mmol)
4 secondary outcomes
Urinary output after 48 hours
Time frame: 48 hours
Urinary sodium excretion on daily base
Time frame: 24 hours
Urinary output on daily base
Time frame: 24 hours
Achievement of decongestion
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
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Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wilfried Mullens, MD PhD principal investigator
Ziekenhuis Oost-Limburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diuretic protocol in people with Acute Decompensated Heart Failure, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary sodium excretion after 48 hours (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.