Investigating a Tailored Diuretic Algorithm in Acute Heart Failure Patients
ConditionHeart Failure Acute
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZuyderland Medisch Centrum
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Urine sodium guided diuretic algorithm
Other interventionLoop 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 care
Other interventionTreatment 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.
Treatment groups
556 Participants
are divided into 2 treatment groupsGroup A: Tailored, Urine sodium guided, intensified diuretic strategyExperimental treatment 1 intervention
Group B: Usual careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 inclusionSecondary outcomes
1
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 hospitalisation2
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 inclusion3
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),4
Quality of life (Kansas City Cardiomyopathy Questionnaire)
Quality of life assessed using the Kansas City Cardiomyopathy Questionnaire
Time frame
90 days after inclusionSponsors and contacts
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Source ClinicalTrials.gov