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

NCT07631780 | Not Yet Recruiting

• 2 other identifiers: 13/2-19-38-7Order №13/2-19-38-7
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Worsening Heart Failure; Congestion; Heart Failure

Keywords

Worsening Heart Failure; Congestion; Natriuresis; Urinary Sodium; Diuretic Therapy; Loop Diuretics; Decongestion; Fluid Overload; Bedside Diagnostics

Outcome Measures

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

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

Secondary Outcomes (6)

• Total and Time-Specific Urinary Sodium Excretion

  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.

• Length of Hospital Stay

  From hospital admission to hospital discharge, assessed up to 30 days.

• Death or Heart Failure Rehospitalization Within 30 Days After Discharge

  From hospital discharge through 30 days after discharge.

• Cumulative Urine Output

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

Other Outcomes (3)

• Incidence of Symptomatic Hypotension

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

• Clinically Significant Electrolyte Disturbances

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

• All-Cause In-Hospital Mortality

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

Study Arms (4)

Standard Treatment

ACTIVE COMPARATOR

Standard urine output-guided decongestive therapy according to institutional practice and predefined treatment protocols.

Drug: Furosemide

Natriuresis-Guided Intermittent IV Bolus

EXPERIMENTAL

Natriuresis-guided decongestive therapy using intermittent intravenous bolus administration of furosemide with dose titration based on urinary sodium assessment.

Drug: Furosemide; Device: Horiba LAQUAtwin B-722

Natriuresis-Guided Continuous Infusion

EXPERIMENTAL

Natriuresis-guided decongestive therapy using continuous intravenous furosemide infusion via infusion pump with dose titration based on urinary sodium assessment.

Drug: Furosemide; Device: Horiba LAQUAtwin B-722

Natriuresis-Guided Prolonged Intermittent Infusion

EXPERIMENTAL

Natriuresis-guided decongestive therapy using prolonged intermittent intravenous furosemide infusion with dose titration based on urinary sodium assessment.

Drug: Furosemide; Device: Horiba LAQUAtwin B-722

Interventions

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.

Natriuresis-Guided Continuous Infusion; Natriuresis-Guided Intermittent IV Bolus; Natriuresis-Guided Prolonged Intermittent Infusion; Standard Treatment

Horiba LAQUAtwin B-722 DEVICE

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

Natriuresis-Guided Continuous Infusion; Natriuresis-Guided Intermittent IV Bolus; Natriuresis-Guided Prolonged Intermittent Infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nurgul Ablakimova: lead
• I.M. Sechenov First Moscow State Medical University: collaborator

Study Sites (1)

West Kazakhstan Marat Ospanov Medical University

Aktobe, 030000, Kazakhstan

Location

Related Publications (3)

• Ter Maaten JM, Beldhuis IE, van der Meer P, Krikken JA, Coster JE, Nieuwland W, van Veldhuisen DJ, Voors AA, Damman K. Natriuresis-guided therapy in acute heart failure: rationale and design of the Pragmatic Urinary Sodium-based treatment algoritHm in Acute Heart Failure (PUSH-AHF) trial. Eur J Heart Fail. 2022 Feb;24(2):385-392. doi: 10.1002/ejhf.2385. Epub 2022 Jan 6.

  PMID: 34791756 BACKGROUND

• Mullens W, Damman K, Harjola VP, Mebazaa A, Brunner-La Rocca HP, Martens P, Testani JM, Tang WHW, Orso F, Rossignol P, Metra M, Filippatos G, Seferovic PM, Ruschitzka F, Coats AJ. The use of diuretics in heart failure with congestion - a position statement from the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2019 Feb;21(2):137-155. doi: 10.1002/ejhf.1369. Epub 2019 Jan 1.

  PMID: 30600580 BACKGROUND

• McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.

  PMID: 34447992 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Edema

Interventions

Furosemide

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Study Officials

• Nurgul Ablakimova, PhD

  West Kazakhstan Marat Ospanov Medical University

  PRINCIPAL INVESTIGATOR

• Vadim Medovchshikov, PhD

  West Kazakhstan Marat Ospanov Medical University

  STUDY DIRECTOR

• Anzhela Soloveva, candidate of medical sciences

  I.M. Sechenov First Moscow State Medical University

  PRINCIPAL INVESTIGATOR

• Svetlana Rachina, doctor of medical sciences

  I.M. Sechenov First Moscow State Medical University

  STUDY CHAIR

• Gaziza Smagulova, candidate of medical sciences

  West Kazakhstan Marat Ospanov Medical University

  STUDY CHAIR

• Ayagoz Meshitbayeva

  West Kazakhstan Marat Ospanov Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Model Details: 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.

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 8, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: De-identified individual participant data and supporting documents will become available beginning 6 months after publication of the primary study results and will remain available for 5 years.
• Access Criteria: Access to de-identified individual participant data and supporting documents will be provided to qualified researchers upon reasonable request to the corresponding author and after approval by the study investigators and participating institution. Data sharing will be limited to non-commercial scientific research purposes and subject to applicable ethical and data protection requirements.

Locations

KA (1)