Congestion, Heart Failure, Worsening Heart Failure
Conditions
Keywords
Worsening Heart Failure, Congestion, Natriuresis, Urinary Sodium, Diuretic Therapy, Loop Diuretics, Decongestion, Fluid Overload, Bedside Diagnostics
Brief summary
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.
Interventions
DRUGFurosemide
Intravenous loop diuretic therapy administered according to predefined treatment algorithms, including intermittent bolus administration, continuous infusion, or prolonged intermittent infusion with protocol-driven dose titration.
DEVICEHoriba LAQUAtwin B-722
Portable point-of-care urinary sodium analyzer used for serial spot urinary sodium measurements to guide decongestive therapy.
Sponsors
Nurgul Ablakimova
I.M. Sechenov First Moscow State Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Due to the nature of the intervention, the study is conducted in an open-label design. Urinary sodium measurements in the standard-of-care group will remain concealed from treating physicians and will not be used for protocol-driven treatment adjustment. Whenever feasible, investigators responsible for outcome assessment and statistical analysis will remain blinded to treatment allocation.
Intervention model description
Participants will be randomized in a parallel-group design to receive either standard urine output-guided therapy or natriuresis-guided decongestive therapy using one of the predefined intravenous furosemide administration regimens. Treatment will be delivered according to the assigned study arm throughout the index hospitalization.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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). * Provision of written informed consent.
Exclusion criteria
* 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. * Recent use (≤48 hours) of inotropic agents affecting fluid and electrolyte balance. * Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m² or requirement for renal replacement therapy. * Hypokalemia (\<3.5 mmol/L) or hyperkalemia (≥5.5 mmol/L). * Clinically significant hyponatremia (\<130 mmol/L) or hypernatremia (\>150 mmol/L). * Significant comorbidities affecting sodium-water balance (e.g., liver cirrhosis with ascites, nephrotic syndrome, severe infection or sepsis). * Pregnancy or breastfeeding. * Active malignancy. * Inability to comply with the study protocol or participation in another interventional clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hierarchical Composite Endpoint of Unsuccessful Decongestion | From randomization through hospital discharge, assessed up to 14 days. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total and Time-Specific Urinary Sodium Excretion | 6, 24, 48, and 72 hours after initiation of intravenous loop diuretic therapy. | Urinary sodium excretion measured at 6, 24, 48, and 72 hours after initiation of intravenous loop diuretic therapy. |
| Time to Clinical Decongestion | From initiation of intravenous loop diuretic therapy until clinical decongestion, assessed up to 14 days. | 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. |
| Length of Hospital Stay | From hospital admission to hospital discharge, assessed up to 30 days. | Duration of hospitalization measured as the number of days from hospital admission to hospital discharge. |
| Death or Heart Failure Rehospitalization Within 30 Days After Discharge | From hospital discharge through 30 days after discharge. | Composite outcome of all-cause mortality or rehospitalization due to worsening heart failure occurring within 30 days after hospital discharge. |
| Cumulative Urine Output | From initiation of intravenous loop diuretic therapy through hospital discharge, assessed up to 14 days. | Total urine output measured during hospitalization. |
| Proportion of Patients Achieving Predefined Natriuresis Targets | Within 72 hours after initiation of intravenous loop diuretic therapy. | Proportion of patients achieving predefined urinary sodium excretion targets according to the study treatment algorithm during the first 72 hours of hospitalization. |
Countries
Kazakhstan
Contacts
PRINCIPAL_INVESTIGATORNurgul Ablakimova, PhD
West Kazakhstan Marat Ospanov Medical University
STUDY_DIRECTORVadim Medovchshikov, PhD
West Kazakhstan Marat Ospanov Medical University
PRINCIPAL_INVESTIGATORAnzhela Soloveva, candidate of medical sciences
I.M. Sechenov First Moscow State Medical University
STUDY_CHAIRSvetlana Rachina, doctor of medical sciences
I.M. Sechenov First Moscow State Medical University
STUDY_CHAIRGaziza Smagulova, candidate of medical sciences
West Kazakhstan Marat Ospanov Medical University
PRINCIPAL_INVESTIGATORAyagoz Meshitbayeva
West Kazakhstan Marat Ospanov Medical University
Outcome results
None listed