SURE-HF: Urinary Sodium-Guided Diuretic Therapy in Heart Failure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNurgul Ablakimova
About this trial
The SURE-HF trial is a pragmatic, multicentre, randomized controlled study evaluating natriuresis-guided optimization of intravenous loop diuretic therapy in patients hospitalized with worsening heart failure (WHF). The study aims to determine whether serial urinary sodium assessment combined with a structured decongestive treatment algorithm improves decongestion, reduces the need for therapy escalation, and enhances discharge readiness compared with standard care.
Participants will be randomized to standard urine output-guided therapy or natriuresis-guided decongestive strategies using different intravenous loop diuretic administration regimens. The study integrates bedside diagnostic tools including lung ultrasound, inferior vena cava assessment, focused echocardiography, and serial clinical congestion monitoring.
The primary endpoint is a hierarchical composite outcome including escalation of heart failure therapy, persistent congestion at discharge, inability to transition to oral loop diuretics by Day 5, and residual ultrasound congestion. The findings of the SURE-HF trial may support implementation of urinary sodium-guided and ultrasound-assisted decongestive therapy in routine heart failure management.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
Confirmed diagnosis of worsening heart failure (WHF), characterized by symptoms and signs of acute decompensation requiring hospitalization for intensification of intravenous diuretic therapy.
Previous intake of a loop diuretic (torasemide or furosemide) in any dose for at least 2 days before hospitalization.
Presence of clinical signs and symptoms of congestion (e.g., dyspnea, orthopnea, peripheral edema, pulmonary congestion).
Disqualifiers
Acute coronary syndrome within the previous 30 days.
Acute heart failure requiring urgent invasive intervention, including cardiogenic shock or mechanical circulatory support.
Current admission to an intensive care unit.
Systolic blood pressure ≤90 mmHg or requirement for inotropic/vasopressor support.
Trial design
Design model
Parallel
Treatments tested in this trial
Furosemide
DrugIntravenous loop diuretic therapy administered according to predefined treatment algorithms, including intermittent bolus administration, continuous infusion, or prolonged intermittent infusion with protocol-driven dose titration.
Horiba LAQUAtwin B-722
DevicePortable point-of-care urinary sodium analyzer used for serial spot urinary sodium measurements to guide decongestive therapy.
Treatment groups
260 Participants
are divided into 4 treatment groupsGroup A: Standard TreatmentActive comparator 1 intervention
Group B: Natriuresis-Guided Intermittent IV BolusExperimental treatment 2 interventions
Group C: Natriuresis-Guided Continuous InfusionExperimental treatment 2 interventions
Group D: Natriuresis-Guided Prolonged Intermittent InfusionExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Hierarchical Composite Endpoint of Unsuccessful Decongestion
1. Escalation of heart failure therapy within the first 5 days of hospitalization. 2. Persistent clinical congestion at hospital discharge, defined as the presence of at least two of the following: dyspnea at rest, orthopnea, pulmonary rales, peripheral edema, or elevated jugular venous pressure. 3. Failure to transition from intravenous to oral loop diuretics by Day 5 of hospitalization. 4. Residual ultrasound congestion at hospital discharge, defined as ≥1 zone with ≥3 B-lines (one positive zone) on each hemithorax using 8-zone scanning
Time frame
From randomization through hospital discharge, assessed up to 14 days.Secondary outcomes
1
Total and Time-Specific Urinary Sodium Excretion
Urinary sodium excretion measured at 6, 24, 48, and 72 hours after initiation of intravenous loop diuretic therapy.
Time frame
6, 24, 48, and 72 hours after initiation of intravenous loop diuretic therapy.2
Time to Clinical Decongestion
Time from initiation of intravenous loop diuretic therapy to achievement of clinical decongestion, defined as resolution of clinical signs and symptoms of congestion, including absence of dyspnea at rest, orthopnea, pulmonary rales, peripheral edema, and elevated jugular venous pressure.
Time frame
From initiation of intravenous loop diuretic therapy until clinical decongestion, assessed up to 14 days.3
Length of Hospital Stay
Duration of hospitalization measured as the number of days from hospital admission to hospital discharge.
Time frame
From hospital admission to hospital discharge, assessed up to 30 days.4
Death or Heart Failure Rehospitalization Within 30 Days After Discharge
Composite outcome of all-cause mortality or rehospitalization due to worsening heart failure occurring within 30 days after hospital discharge.
Time frame
From hospital discharge through 30 days after discharge.Other outcomes
1
Incidence of Symptomatic Hypotension
Occurrence of symptomatic hypotension during hospitalization.
Time frame
From randomization through hospital discharge, assessed up to 14 days.2
Clinically Significant Electrolyte Disturbances
Occurrence of clinically significant abnormalities in serum potassium or sodium during hospitalization.
Time frame
From baseline through hospital discharge, assessed up to 14 days.3
All-Cause In-Hospital Mortality
Death from any cause occurring during hospitalization.
Time frame
From randomization through hospital discharge, assessed up to 14 days.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Nurgul Ablakimova
Lead sponsor
West Kazakhstan Marat Ospanov Medical University
Sponsor institution
I.M. Sechenov First Moscow State Medical University
Collaborator
Source ClinicalTrials.gov
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