Heart Failure AcuteTAILOR-AHFNCT06092437
Investigating a Tailored Diuretic Algorithm in Acute Heart Failure Patients
A study testing Urine sodium guided diuretic algorithm in people with Heart Failure Acute, run by Zuyderland Medisch Centrum at 2 sites in Netherlands.
Trial summary
Acutely decompensated heart failure (ADHF) is highly prevalent and has a high (financial) burden on the health care system. Treatment often consists of the administration of IV decongestive agents. Adequate dosing is difficult due to varying diuretic resistance and inadequate parameters to evaluate the response. 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?
- Urine sodium guided diuretic algorithm
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 556 participants
- Where
- 2 sitesNetherlands
- Study dates
- 27 Feb 2023to 27 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age > 18 years;
- HF (HFrEF, HFmrEF or HFpEF) diagnosed according to the 2021 HF Guidelines of the European Society of Cardiology [5];
- Presentation with AHF meaning at least one symptom (dyspnea, orthopnea, or edema) and one sign (rales, peripheral edema, ascites, or pulmonary vascular congestion on chest radiography) of AHF;
- An elevated NT-proBNP >300pg/ml;
- Requiring the need for iv diuretics.
Who cannot join
- Terminal renal insufficiency defined as: dialysis patients or eGFR (estimated glomerular filtration rate) < 10 mL/min/1.73 m2;
- Patients included in other investigational studies regarding heart failure.
- Presentation with cardiogenic shock or respiratory insufficiency or another reason requiring admission to the intensive care unit upon admission (IC transfer later in the hospitalization is not an exclusion).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 2 recruiting
- Recruiting
Amphia ziekenhuis
Breda, North Brabant, 4818 CK
Ijsbrand dr. Klip, MD, PhD, +31765953018, RDCardio@amphia.nl
Ijsbrand Dr. Klip, MD, PhD
- Recruiting
Zuyderland MC
Heerlen, Limburg, 6419 PC
Sandra van Wijk, MD, PhD, 088 - 459 9701
Mick Hoen, MD, 088 - 459 9701
About this study
Official title: TAILOR-AHF: Randomized Trial Investigating a Tailored Diuretic Algorithm in Acute Heart Failure Patients
Acutely decompensated heart failure (ADHF) is highly prevalent and has a high (financial) burden on the health care system. Treatment often consists of the administration of IV decongestive agents. Adequate dosing is difficult due to varying diuretic resistance and inadequate parameters to evaluate the response. Urine sodium is a promising biomarker to evaluate the diuretic response. It is hypothesized that a tailored, urine sodium guided diuretic algorithm will result in faster and more complete decongestion and therefore lead to better survival (in terms of mortality and heart failure events) while being non-inferior in terms of safety (mainly regression of kidney function).
Read the detailed description
Rationale: Acutely decompensated heart failure is a highly prevalent diagnosis with a high burden on resources and a high risk of mortality and re-hospitalization. The prescription of diuretics to relieve congestion has been the cornerstone of treatment for years, but evidence about diuretic response and adequate dosing is still lacking. Inadequate diuretic response (and insufficient decongestion) has a negative influence on outcome but is often not timely addressed. Urinary sodium (Ur-Na) is a promising biomarker in the prediction of diuretic response to the prescribed dose. It is hypothesized that an Ur-Na based, intensified algorithm can help tailor diuretics in an individual way, but sufficient evidence to support its implementation is lacking.
Objective: Investigate if a tailored diuretic algorithm based on Ur-Na has a positive effect on a primary endpoint of reduction in a combined endpoint of death, heart failure events and change in the Kansas City questionnaire total symptom score (KCCQ-TSS) versus standard clinical care in patients hospitalized with AHF, without imposing safety concerns (e.g. worsening renal function).
Study design: Prospective, Single-Blinded, Randomized, Blinded-endpoint trial
Study population: Patients admitted with acutely decompensated heart failure (diagnosed according to the 2021 ESC (European Society of Cardiology) guidelines) who are 18 year or older.
Intervention: Arm I: Tailored, Ur-Na based, intensified diuretic strategy; Arm II: Usual care
Main study parameters/endpoints: Hierarchical composite endpoint of all-cause death, heart failure events and a 4-point or greater difference in Kansas City questionnaire total symptom score (KCCQ-TSS); assessed using a win-ratio approach.
- Conditions
- Heart Failure Acute
- Being tested
- Urine sodium guided diuretic algorithm, Usual care
- Keywords
- Decongestion, Heart failure, Natriuresis, Urinary Sodium
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine sodium guided diuretic algorithmOther
Loop diuretics are administered intravenously as soon as possible after diagnosis of ADHF and continued 3dd until recompensation. Spot urine sodium is measured 2 hours after administration of the first in-hospital IV diuretic dose and repeated until the target of 100mmol/L is reached in the first 72 hours of admission (after which, UrNa will be measured once daily). When target is not met, the next dosage of loop diuretic is doubled (max 3dd 250mg furosemide) and thereafter, other diuretics (thiazide, MRA) are added. Acetazolamide in the first 72 hours is advised as background therapy in both treatment arms.
Usual careOther
Treatment with IV loop diuretics left to the discretion of the treating physician. Acetazolamide in the first 72 hours is advised as background therapy in both treatment arms.
| Study group | Role | What they receive |
|---|---|---|
| Tailored, Urine sodium guided, intensified diuretic strategy | Experimental | Not described Receives: Other: Urine sodium guided diuretic algorithm |
| Usual care | Active comparator | Not described Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hierarchical composite of all-cause mortality, heart failure events and delta quality of life at 90 days follow-up.
The primary endpoint is a hierarchical composite calculated using a win-ratio approach of:
- Mortality (all-cause) at 90 days after hospitalization; ii) Heart failure events at 90 days after hospitalization (1. a >2 times increase in oral loop diuretic dose, 2. the need for iv administration of loop diuretics, 3. an emergency department visit or hospitalization for HF), wherein a single event or hospitalization will be sufficient to reach the combined endpoint; iii) Delta in quality of life measured using the Kansas City Cardiomyopathy Questionnaire total symptom score (KCCQ-TSS) from baseline to 90 days after hospitalization
Measured: 90 days after inclusion
Secondary outcomes (15)
Delta NT-pro BNP
Delta NT-proBNP from admission to discharge and 90-days follow up
Measured: From admission to discharge and 90 days after hospitalisation
Successful decongestion
Number of participants with successful decongestion (defined as a clinical congestion score of 2 or less and NYHA I-II)
Measured: Day 3 after inclusion
Change in clinical congestion score
Change in clinical congestion score from admission to discharge
Measured: From date of randomization until date of hospital discharge (regarding initial hospitalisation at time of randomisation, assessed up to 90 days),
Quality of life (Kansas City Cardiomyopathy Questionnaire)
Quality of life assessed using the Kansas City Cardiomyopathy Questionnaire
Measured: 90 days after inclusion
Adverse (safety) events
All-cause readmissions at 90-days, all-cause and cardiovascular mortality at 90-days, (symptomatic) hypotension, hypokalemia, urinary tract infection, phlebitis, atrial fibrillation, fall/trauma and decompensated HF
Measured: 90 days after inclusion
All-cause mortality and heart failure readmissions
All-cause mortality and heart failure readmissions at 14 days follow up
Measured: 14 days after inclusion
All-cause mortality and heart failure readmissions
All-cause mortality and heart failure readmissions at 6 months follow up
Measured: 6 months after inclusion
Chronic dialysis
Occurence of the need for chronic dialysis at 90-days follow up
Measured: 90 days after inclusion
Days alive outside the hospital
Days alive outside the hospital at 90-days follow up
Measured: 90 days after inclusion
Time to first heart failure hospitalization and number of heart failure hospitalizations
Time to first heart failure hospitalization and number of heart failure hospitalizations
Measured: 90 days after inclusion
Number of outpatient visits
Number of outpatient visits in the first 90 days
Measured: 90 days after inclusion
Number of worsening heart failure events
Number of worsening heart failure events at 90 days:
- a >2 times increase in oral loop diuretic dose, ii) the need for iv administration of loop diuretics, iii) an emergency department visit or hospitalization for HF
Measured: 90 days after inclusion
Delta weight
Delta weight (in kilograms) from admission to discharge
Measured: From date of randomization until date of hospital discharge (regarding initial hospitalisation at time of randomisation, assessed up to 90 days)
Hospital length of stay
Number of days from hospitalization untill discharge or end of clinical treatment (not including days waiting for post-hospital care)
Measured: Number of days from hospitalization untill end of clinical treatment (not including days waiting for post-hospital care) or hospital discharge, whichever came first, assessed up to 90 days after randomization.
Worsening renal function
Delta creatinine from baseline until discharge and 90 days follow-up
Measured: Baseline until 90 days follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start27 Feb 2023
- Primary completion27 Jun 2026 (estimated)
- Study completion27 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 556 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zuyderland Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092437
- Sponsor's protocol ID
- Z2021110
- Acronym
- TAILOR-AHF
- Status last verified
- Mar 2026
- First submitted
- 31 Aug 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TAILOR-AHF: Randomized Trial Investigating a Tailored Diuretic Algorithm in Acute Heart Failure Patients
- ClinicalTrials.gov ID
- NCT06092437
- Acronym / sponsor ID
- TAILOR-AHF / Z2021110
- Conditions
- Heart Failure Acute
- Keywords
- Decongestion, Heart failure, Natriuresis, Urinary Sodium
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 556 participants (estimated)
- Lead sponsor
- Zuyderland Medisch CentrumUniversity, hospital or other
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 27 Jun 2026 (estimated)
- Study completion
- 27 Aug 2026 (estimated)
- First posted
- 23 Oct 2023 (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.
Acutely decompensated heart failure (ADHF) is highly prevalent and has a high (financial) burden on the health care system. Treatment often consists of the administration of IV decongestive agents. Adequate dosing is difficult due to varying diuretic resistance and inadequate parameters to evaluate the response. Urine sodium is a promising biomarker to evaluate the diuretic response. It is hypothesized that a tailored, urine sodium guided diuretic algorithm will result in faster and more complete decongestion and therefore lead to better survival (in terms of mortality and heart failure events) while being non-inferior in terms of safety (mainly regression of kidney function).
Detailed description
Rationale: Acutely decompensated heart failure is a highly prevalent diagnosis with a high burden on resources and a high risk of mortality and re-hospitalization. The prescription of diuretics to relieve congestion has been the cornerstone of treatment for years, but evidence about diuretic response and adequate dosing is still lacking. Inadequate diuretic response (and insufficient decongestion) has a negative influence on outcome but is often not timely addressed. Urinary sodium (Ur-Na) is a promising biomarker in the prediction of diuretic response to the prescribed dose. It is hypothesized that an Ur-Na based, intensified algorithm can help tailor diuretics in an individual way, but sufficient evidence to support its implementation is lacking.
Objective: Investigate if a tailored diuretic algorithm based on Ur-Na has a positive effect on a primary endpoint of reduction in a combined endpoint of death, heart failure events and change in the Kansas City questionnaire total symptom score (KCCQ-TSS) versus standard clinical care in patients hospitalized with AHF, without imposing safety concerns (e.g. worsening renal function).
Study design: Prospective, Single-Blinded, Randomized, Blinded-endpoint trial
Study population: Patients admitted with acutely decompensated heart failure (diagnosed according to the 2021 ESC (European Society of Cardiology) guidelines) who are 18 year or older.
Intervention: Arm I: Tailored, Ur-Na based, intensified diuretic strategy; Arm II: Usual care
Main study parameters/endpoints: Hierarchical composite endpoint of all-cause death, heart failure events and a 4-point or greater difference in Kansas City questionnaire total symptom score (KCCQ-TSS); assessed using a win-ratio approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tailored, Urine sodium guided, intensified diuretic strategy | Experimental | Other: Urine sodium guided diuretic algorithm |
| Usual care | Active comparator | Other: Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years;
- HF (HFrEF, HFmrEF or HFpEF) diagnosed according to the 2021 HF Guidelines of the European Society of Cardiology [5];
- Presentation with AHF meaning at least one symptom (dyspnea, orthopnea, or edema) and one sign (rales, peripheral edema, ascites, or pulmonary vascular congestion on chest radiography) of AHF;
- An elevated NT-proBNP >300pg/ml;
- Requiring the need for iv diuretics.
Key exclusion criteria (3 listed)
- Terminal renal insufficiency defined as: dialysis patients or eGFR (estimated glomerular filtration rate) < 10 mL/min/1.73 m2;
- Patients included in other investigational studies regarding heart failure.
- Presentation with cardiogenic shock or respiratory insufficiency or another reason requiring admission to the intensive care unit upon admission (IC transfer later in the hospitalization is not an exclusion).
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 |
|---|---|---|
| Urine sodium guided diuretic algorithmLoop diuretics are administered intravenously as soon as possible after diagnosis of ADHF and continued 3dd until recompensation. Spot urine sodium is measured 2 hours after administration of the first in-hospital IV diuretic dose and repeated until the target of 100mmol/L is reached in the first 72 hours of admission (after which, UrNa will be measured once daily). When target is not met, the next dosage of loop diuretic is doubled (max 3dd 250mg furosemide) and thereafter, other diuretics (thiazide, MRA) are added. Acetazolamide in the first 72 hours is advised as background therapy in both treatment arms. | Other | Tailored, Urine sodium guided, intensified diuretic strategy |
| Usual careTreatment with IV loop diuretics left to the discretion of the treating physician. Acetazolamide in the first 72 hours is advised as background therapy in both treatment arms. | Other | Usual care |
Primary outcome
Hierarchical composite of all-cause mortality, heart failure events and delta quality of life at 90 days follow-up.
Time frame: 90 days after inclusion
The primary endpoint is a hierarchical composite calculated using a win-ratio approach of: i) Mortality (all-cause) at 90 days after hospitalization; ii) Heart failure events at 90 days after hospitalization (1. a >2 times increase in oral loop diuretic dose, 2. the need for iv administration of loop diuretics, 3. an emergency department visit or hospitalization for HF), wherein a single event or hospitalization will be sufficient to reach the combined endpoint; iii) Delta in quality of life measured using the Kansas City Cardiomyopathy Questionnaire total symptom score (KCCQ-TSS) from baseline to 90 days after hospitalization
15 secondary outcomes
Delta NT-pro BNP
Time frame: From admission to discharge and 90 days after hospitalisation
Successful decongestion
Time frame: Day 3 after inclusion
Change in clinical congestion score
Time frame: From date of randomization until date of hospital discharge (regarding initial hospitalisation at time of randomisation, assessed up to 90 days),
Quality of life (Kansas City Cardiomyopathy Questionnaire)
Time frame: 90 days after inclusion
Adverse (safety) events
Time frame: 90 days after inclusion
All-cause mortality and heart failure readmissions
Time frame: 14 days after inclusion
All-cause mortality and heart failure readmissions
Time frame: 6 months after inclusion
Chronic dialysis
Time frame: 90 days after inclusion
Days alive outside the hospital
Time frame: 90 days after inclusion
Time to first heart failure hospitalization and number of heart failure hospitalizations
Time frame: 90 days after inclusion
Number of outpatient visits
Time frame: 90 days after inclusion
Number of worsening heart failure events
Time frame: 90 days after inclusion
Delta weight
Time frame: From date of randomization until date of hospital discharge (regarding initial hospitalisation at time of randomisation, assessed up to 90 days)
Hospital length of stay
Time frame: Number of days from hospitalization untill end of clinical treatment (not including days waiting for post-hospital care) or hospital discharge, whichever came first, assessed up to 90 days after randomization.
Worsening renal function
Time frame: Baseline until 90 days follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urine sodium guided diuretic algorithm in people with Heart Failure Acute, run by Zuyderland Medisch Centrum at 2 sites 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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandra van Wijk, MD, PhD (088 - 459 9701, s.vanwijk@zuyderland.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hierarchical composite of all-cause mortality, heart failure events and delta quality of life at 90 days follow-up. (time frame: 90 days after inclusion). 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 13 Apr 2026.