Heart Failure AcutePUSH-AHFNCT04606927
Pragmatic Urinary Sodium-based Treatment algoritHm in Acute Heart Failure
A study testing Natriuresis in people with Heart Failure Acute, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Administration of loop diuretics to achieve decongestion is the current cornerstone of therapy for acute heart failure. Unfortunately, there is a lack of evidence of how to guide diuretic treatment. Recently, urinary sodium, as a response measure of diuretic response, has been proposed as a target for therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure Acute
- What is being tested?
- Natriuresis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Feb 2021to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female ≥ 18 years of age
- Primary diagnosis of acute /decompensated heart failure as assessed by treating physician
- Acute Heart failure can be de novo or exacerbation of known heart failure and diagnosis is based on criteria in the ESC HF guidelines
- Requirement of intravenous diuretic use
Who cannot join
- Dyspnoea primarily due to non-cardiac causes
- Patients with severe renal impairment receiving dialysis or requiring ultrafiltration
- Inability to follow instructions
- Any other medical conditions that may put the patient at risk or influence study results in the investigator's opinion, or that the investigator deems unsuitable for the study
Trial locations and contacts
1 site in 1 country.
About this study
Administration of loop diuretics to achieve decongestion is the current cornerstone of therapy for acute heart failure. Unfortunately, there is a lack of evidence of how to guide diuretic treatment. Recently, urinary sodium, as a response measure of diuretic response, has been proposed as a target for therapy. The hypothesis of this study is that natriuresis guided therapy in patients with acute heart failure will improve diuretic response, decongestion, and reduce length of hospital stay, as well as heart failure rehospitalisations.
Read the detailed description
Objective: To assess the effect of natriuresis guided therapy in acute heart failure to improve diuretic response, decongestion, and clinical outcomes
Study design: Randomised, controlled, open label study
Study population: 310 patients admitted with the primary diagnosis of acute heart failure requiring intravenous loop diuretics.
Intervention: natriuresis guided treatment versus standard of care
Main study parameters/endpoints:
Co-primary outcome: total natriuresis after 24 hours, and first occurrence of all-cause mortality or heart failure rehospitalisation at 6 months Secondary outcomes: 48- and 72-hours natriuresis, length of hospital stay, percentage change in NT-proBNP at 48 and 72 hours.
Safety endpoint: doubling of serum creatinine at 24 or 48 hours, worsening heart failure.
- Conditions
- Heart Failure Acute
- Being tested
- Natriuresis
- Keywords
- loop diuretics, natriuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NatriuresisOther
Patients with insufficient decongestive response based on natriuresis (in the active arm) will be eligible for treatment adjustments according to the natriuresis guided treatment algorithm.
| Study group | Role | What they receive |
|---|---|---|
| Natriuresis guided treatment | Active comparator | Not described Receives: Other: Natriuresis |
| Standard of care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Natriuresis After 24 Hours
The first component of the co-primary end-point is total natriuresis after 24 h (mmol). To assess this, urine is collected for 24 hours after the first administration of diuretics according to the study protocol and natriuresis is calculated as the total amount of diuresis (L) multiplied by the urinary sodium concentration (mmol/L).
Measured: 24 hours
First Occurrence of All-cause Mortality or Heart Failure Rehospitalization After 180 Days
Measured: 180 days
Secondary outcomes (5)
48-hours Natriuresis
48-hour natriuresis will be assessed by collecting urine for a second period of 24 hours after the first 24-hour urine collection according to the study protocol and natriuresis is calculated as the total amount of diuresis (L) multiplied by the urinary sodium concentration (mmol/L).
Measured: 48 hours
72-hours Natriuresis
72-hour natriuresis will be assessed by collecting urine for a third period of 24 hours after the second 24-hour urine collection according to the study protocol and natriuresis is calculated as the total amount of diuresis (L) multiplied by the urinary sodium concentration (mmol/L).
Measured: 72 hours
Length of Hospital Stay
Number of days of the index hospitalization
Measured: Variable
Percentage Change in NT-proBNP at 48 Hours
Relative NT-proBNP change (%) after 48 hours compared with baseline
Measured: 48 hours
Percentage Change in NT-proBNP at 72 Hours
Relative NT-proBNP change (%) after 72 hours compared with baseline
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start1 Feb 2021
- Primary completion9 May 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart Failure AcuteStudies 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
- Masking
- None (open label)
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jozine ter Maaten, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606927
- Sponsor's protocol ID
- 2020000710
- Acronym
- PUSH-AHF
- Status last verified
- Nov 2023
- First submitted
- 18 Oct 2020
- Last updated
- 22 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zonneveld LEEC, Pandey A, Beldhuis IE, van der Meer P, Coster JE, Nieuwland W, Trullas JC, van Veldhuisen DJ, Voors AA, Damman K, Ter Maaten JM. Diuretic Resistance Risk and the Efficacy of Natriuresis-Guided Diuretic Therapy in Acute Heart Failure: Post Hoc Analysis From the PUSH-AHF Trial. JACC Heart Fail. 2026 Jul;14(7):103017. doi: 10.1016/j.jchf.2026.103017. Epub 2026 Mar 27.
PubMed 41893376Ter Maaten JM, Beldhuis IE, van der Meer P, Krikken JA, Postmus D, Coster JE, Nieuwland W, van Veldhuisen DJ, Voors AA, Damman K. Natriuresis-guided diuretic therapy in acute heart failure: a pragmatic randomized trial. Nat Med. 2023 Oct;29(10):2625-2632. doi: 10.1038/s41591-023-02532-z. Epub 2023 Aug 28.
PubMed 37640861
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Urinary Sodium-based Treatment algoritHm in Acute Heart Failure
- ClinicalTrials.gov ID
- NCT04606927
- Acronym / sponsor ID
- PUSH-AHF / 2020000710
- Conditions
- Heart Failure Acute
- Keywords
- loop diuretics, natriuresis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 9 May 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 28 Oct 2020 (actual)
- Results
- Posted 22 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Administration of loop diuretics to achieve decongestion is the current cornerstone of therapy for acute heart failure. Unfortunately, there is a lack of evidence of how to guide diuretic treatment. Recently, urinary sodium, as a response measure of diuretic response, has been proposed as a target for therapy. The hypothesis of this study is that natriuresis guided therapy in patients with acute heart failure will improve diuretic response, decongestion, and reduce length of hospital stay, as well as heart failure rehospitalisations.
Detailed description
Objective: To assess the effect of natriuresis guided therapy in acute heart failure to improve diuretic response, decongestion, and clinical outcomes
Study design: Randomised, controlled, open label study
Study population: 310 patients admitted with the primary diagnosis of acute heart failure requiring intravenous loop diuretics.
Intervention: natriuresis guided treatment versus standard of care
Main study parameters/endpoints:
Co-primary outcome: total natriuresis after 24 hours, and first occurrence of all-cause mortality or heart failure rehospitalisation at 6 months Secondary outcomes: 48- and 72-hours natriuresis, length of hospital stay, percentage change in NT-proBNP at 48 and 72 hours.
Safety endpoint: doubling of serum creatinine at 24 or 48 hours, worsening heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Natriuresis guided treatment | Active comparator | Other: Natriuresis |
| Standard of care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female ≥ 18 years of age
- Primary diagnosis of acute /decompensated heart failure as assessed by treating physician
- Requirement of intravenous diuretic use
Key exclusion criteria (4 listed)
- Dyspnoea primarily due to non-cardiac causes
- Patients with severe renal impairment receiving dialysis or requiring ultrafiltration
- Inability to follow instructions
- Any other medical conditions that may put the patient at risk or influence study results in the investigator's opinion, or that the investigator deems unsuitable for the study
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 |
|---|---|---|
| NatriuresisPatients with insufficient decongestive response based on natriuresis (in the active arm) will be eligible for treatment adjustments according to the natriuresis guided treatment algorithm. | Other | Natriuresis guided treatment |
Primary outcome
Total Natriuresis After 24 Hours
Time frame: 24 hours
The first component of the co-primary end-point is total natriuresis after 24 h (mmol). To assess this, urine is collected for 24 hours after the first administration of diuretics according to the study protocol and natriuresis is calculated as the total amount of diuresis (L) multiplied by the urinary sodium concentration (mmol/L).
First Occurrence of All-cause Mortality or Heart Failure Rehospitalization After 180 Days
Time frame: 180 days
5 secondary outcomes
48-hours Natriuresis
Time frame: 48 hours
72-hours Natriuresis
Time frame: 72 hours
Length of Hospital Stay
Time frame: Variable
Percentage Change in NT-proBNP at 48 Hours
Time frame: 48 hours
Percentage Change in NT-proBNP at 72 Hours
Time frame: 72 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41893376Zonneveld LEEC, Pandey A, Beldhuis IE, van der Meer P, Coster JE, Nieuwland W, Trullas JC, van Veldhuisen DJ, Voors AA, Damman K, Ter Maaten JM. Diuretic Resistance Risk and the Efficacy of Natriuresis-Guided Diuretic Therapy in Acute Heart Failure: Post Hoc Analysis From the PUSH-AHF Trial. JACC Heart Fail. 2026 Jul;14(7):103017. doi: 10.1016/j.jchf.2026.103017. Epub 2026 Mar 27.
- Derived from this study: PubMed 37640861Ter Maaten JM, Beldhuis IE, van der Meer P, Krikken JA, Postmus D, Coster JE, Nieuwland W, van Veldhuisen DJ, Voors AA, Damman K. Natriuresis-guided diuretic therapy in acute heart failure: a pragmatic randomized trial. Nat Med. 2023 Oct;29(10):2625-2632. doi: 10.1038/s41591-023-02532-z. Epub 2023 Aug 28.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Natriuresis in people with Heart Failure Acute, run by University Medical Center Groningen at 1 site in Netherlands.
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 4 inclusion and 4 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 22 Apr 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 Netherlands. 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?
Yes. Results are posted in the registry (first posted 22 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Natriuresis After 24 Hours (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04606927, which also lists 2 linked publications.
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 22 Apr 2024.