An interventional study of Urine sodium guided diuretic algorithm and Usual care in Heart Failure Acute, sponsored by Zuyderland Medisch Centrum. Recruiting at 2 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Zuyderland Medisch Centrum · Not applicable, Interventional, and Treatment
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).
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.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 556 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Urine sodium guided diuretic algorithm
Other: Usual care
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.
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.
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: 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
Time frame: 90 days after inclusion
Delta NT-pro BNP
Delta NT-proBNP from admission to discharge and 90-days follow up
Time frame: 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)
Time frame: Day 3 after inclusion
Change in clinical congestion score
Change in clinical congestion score from admission to discharge
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)
Quality of life assessed using the Kansas City Cardiomyopathy Questionnaire
Time frame: 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
Time frame: 90 days after inclusion
All-cause mortality and heart failure readmissions
All-cause mortality and heart failure readmissions at 14 days follow up
Time frame: 14 days after inclusion
All-cause mortality and heart failure readmissions
All-cause mortality and heart failure readmissions at 6 months follow up
Time frame: 6 months after inclusion
Chronic dialysis
Occurence of the need for chronic dialysis at 90-days follow up
Time frame: 90 days after inclusion
Days alive outside the hospital
Days alive outside the hospital at 90-days follow up
Time frame: 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
Time frame: 90 days after inclusion
Number of outpatient visits
Number of outpatient visits in the first 90 days
Time frame: 90 days after inclusion
Number of worsening heart failure events
Number of worsening heart failure events at 90 days: i) 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
Time frame: 90 days after inclusion
Delta weight
Delta weight (in kilograms) from admission to discharge
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
Number of days from hospitalization untill discharge or end of clinical treatment (not including days waiting for post-hospital care)
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
Delta creatinine from baseline until discharge and 90 days follow-up
Time frame: Baseline until 90 days follow-up
Plan to share: No
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Zuyderland Medisch Centrum