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

1 giugno 2026 aggiornato da: Nurgul Ablakimova

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)

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

260

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Standard Treatment
Standard urine output-guided decongestive therapy according to institutional practice and predefined treatment protocols.
Droga: Furosemide
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.
Sperimentale: Natriuresis-Guided Intermittent IV Bolus
Natriuresis-guided decongestive therapy using intermittent intravenous bolus administration of furosemide with dose titration based on urinary sodium assessment.
Droga: Furosemide
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.
Dispositivo: Horiba LAQUAtwin B-722
Portable point-of-care urinary sodium analyzer used for serial spot urinary sodium measurements to guide decongestive therapy.
Sperimentale: Natriuresis-Guided Continuous Infusion
Natriuresis-guided decongestive therapy using continuous intravenous furosemide infusion via infusion pump with dose titration based on urinary sodium assessment.
Droga: Furosemide
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.
Dispositivo: Horiba LAQUAtwin B-722
Portable point-of-care urinary sodium analyzer used for serial spot urinary sodium measurements to guide decongestive therapy.
Sperimentale: Natriuresis-Guided Prolonged Intermittent Infusion
Natriuresis-guided decongestive therapy using prolonged intermittent intravenous furosemide infusion with dose titration based on urinary sodium assessment.
Droga: Furosemide
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.
Dispositivo: Horiba LAQUAtwin B-722
Portable point-of-care urinary sodium analyzer used for serial spot urinary sodium measurements to guide decongestive therapy.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Hierarchical Composite Endpoint of Unsuccessful Decongestion
Lasso di tempo: 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
From randomization through hospital discharge, assessed up to 14 days.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Total and Time-Specific Urinary Sodium Excretion
Lasso di tempo: 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.
6, 24, 48, and 72 hours after initiation of intravenous loop diuretic therapy.
Time to Clinical Decongestion
Lasso di tempo: 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.
From initiation of intravenous loop diuretic therapy until clinical decongestion, assessed up to 14 days.
Length of Hospital Stay
Lasso di tempo: 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.
From hospital admission to hospital discharge, assessed up to 30 days.
Death or Heart Failure Rehospitalization Within 30 Days After Discharge
Lasso di tempo: 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.
From hospital discharge through 30 days after discharge.
Cumulative Urine Output
Lasso di tempo: From initiation of intravenous loop diuretic therapy through hospital discharge, assessed up to 14 days.
Total urine output measured during hospitalization.
From initiation of intravenous loop diuretic therapy through hospital discharge, assessed up to 14 days.
Proportion of Patients Achieving Predefined Natriuresis Targets
Lasso di tempo: 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.
Within 72 hours after initiation of intravenous loop diuretic therapy.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of Symptomatic Hypotension
Lasso di tempo: From randomization through hospital discharge, assessed up to 14 days.
Occurrence of symptomatic hypotension during hospitalization.
From randomization through hospital discharge, assessed up to 14 days.
Clinically Significant Electrolyte Disturbances
Lasso di tempo: From baseline through hospital discharge, assessed up to 14 days.
Occurrence of clinically significant abnormalities in serum potassium or sodium during hospitalization.
From baseline through hospital discharge, assessed up to 14 days.
All-Cause In-Hospital Mortality
Lasso di tempo: From randomization through hospital discharge, assessed up to 14 days.
Death from any cause occurring during hospitalization.
From randomization through hospital discharge, assessed up to 14 days.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Nurgul Ablakimova

Collaboratori

I.M. Sechenov First Moscow State Medical University

Investigatori

  • Investigatore principale: Nurgul Ablakimova, PhD, West Kazakhstan Marat Ospanov Medical University
  • Direttore dello studio: Vadim Medovchshikov, PhD, West Kazakhstan Marat Ospanov Medical University
  • Investigatore principale: Anzhela Soloveva, candidate of medical sciences, I.M. Sechenov First Moscow State Medical University
  • Cattedra di studio: Svetlana Rachina, doctor of medical sciences, I.M. Sechenov First Moscow State Medical University
  • Cattedra di studio: Gaziza Smagulova, candidate of medical sciences, West Kazakhstan Marat Ospanov Medical University
  • Investigatore principale: Ayagoz Meshitbayeva, West Kazakhstan Marat Ospanov Medical University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 dicembre 2027

Completamento dello studio (Stimato)

1 dicembre 2027

Date di iscrizione allo studio

Primo inviato

27 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

1 giugno 2026

Primo Inserito (Effettivo)

8 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 giugno 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 13/2-19-38-7
  • Order №13/2-19-38-7 (Altro numero di sovvenzione/finanziamento: West Kazakhstan Marat Ospanov medical university)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

De-identified individual participant data underlying the reported results may be shared upon reasonable request to the corresponding author following publication of the primary study results, subject to institutional approval and applicable data protection regulations.

Periodo di condivisione IPD

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.

Criteri di accesso alla condivisione IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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