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NCT Number: NCT07631780

SURE-HF: Urinary Sodium-Guided Diuretic Therapy in Heart Failure

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.

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Key information

Conditions

Worsening Heart Failure Cardiovascular Diseases Congestion Edema Heart Diseases Heart Failure Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West Kazakhstan Marat Ospanov Medical University

Aktobe, 030000, Kazakhstan

Location contact

Ayagoz Meshitbayeva

CONTACT

[email protected]

77714040296

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Furosemide

Drug

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.

Horiba LAQUAtwin B-722

Device

Portable point-of-care urinary sodium analyzer used for serial spot urinary sodium measurements to guide decongestive therapy.

Primary outcomes

  1. Hierarchical Composite Endpoint of Unsuccessful Decongestion

    Time frame: From randomization through hospital discharge, assessed up to 14 days.

    • Escalation of heart failure therapy within the first 5 days of hospitalization.
    • 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.
    • Failure to transition from intravenous to oral loop diuretics by Day 5 of hospitalization.
    • 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 outcomes

  1. Total and Time-Specific Urinary Sodium Excretion

    Time frame: 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.

  2. Time to Clinical Decongestion

    Time frame: 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.

  3. Length of Hospital Stay

    Time frame: 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.

  4. Death or Heart Failure Rehospitalization Within 30 Days After Discharge

    Time frame: 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.

  5. Cumulative Urine Output

    Time frame: From initiation of intravenous loop diuretic therapy through hospital discharge, assessed up to 14 days.

    Total urine output measured during hospitalization.

  6. Proportion of Patients Achieving Predefined Natriuresis Targets

    Time frame: 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.

Other outcomes

  1. Incidence of Symptomatic Hypotension

    Time frame: From randomization through hospital discharge, assessed up to 14 days.

    Occurrence of symptomatic hypotension during hospitalization.

  2. Clinically Significant Electrolyte Disturbances

    Time frame: From baseline through hospital discharge, assessed up to 14 days.

    Occurrence of clinically significant abnormalities in serum potassium or sodium during hospitalization.

  3. All-Cause In-Hospital Mortality

    Time frame: From randomization through hospital discharge, assessed up to 14 days.

    Death from any cause occurring during hospitalization.

Sponsors and collaborators

Lead sponsor

Nurgul Ablakimova

Other

Collaborators

  • I.M. Sechenov First Moscow State Medical University

Registry information

Official study title

Urinary Sodium-Guided Optimization of Diuretic Therapy in Patients With Worsening Heart Failure: Rationale and Design of a Pragmatic Randomized Controlled Trial (SURE-HF Trial)

Acronym: SURE-HF

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 8, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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