SURE-HF: Urinary Sodium-Guided Diuretic Therapy in Heart Failure (SURE-HF)
1 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
260
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Aktobe, Kazakhstan, 030000
- West Kazakhstan Marat Ospanov Medical University
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Contact:
- Ayagoz Meshitbayeva
- Numéro de téléphone: 77714040296
- E-mail: ayagozmeshitbayeva@gmail.com
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: Standard Treatment
Standard urine output-guided decongestive therapy according to institutional practice and predefined treatment protocols.
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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.
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Expérimental: Natriuresis-Guided Intermittent IV Bolus
Natriuresis-guided decongestive therapy using intermittent intravenous bolus administration of furosemide with dose titration based on urinary sodium assessment.
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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.
Portable point-of-care urinary sodium analyzer used for serial spot urinary sodium measurements to guide decongestive therapy.
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Expérimental: Natriuresis-Guided Continuous Infusion
Natriuresis-guided decongestive therapy using continuous intravenous furosemide infusion via infusion pump with dose titration based on urinary sodium assessment.
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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.
Portable point-of-care urinary sodium analyzer used for serial spot urinary sodium measurements to guide decongestive therapy.
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Expérimental: Natriuresis-Guided Prolonged Intermittent Infusion
Natriuresis-guided decongestive therapy using prolonged intermittent intravenous furosemide infusion with dose titration based on urinary sodium assessment.
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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.
Portable point-of-care urinary sodium analyzer used for serial spot urinary sodium measurements to guide decongestive therapy.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Hierarchical Composite Endpoint of Unsuccessful Decongestion
Délai: From randomization through hospital discharge, assessed up to 14 days.
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From randomization through hospital discharge, assessed up to 14 days.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Total and Time-Specific Urinary Sodium Excretion
Délai: 6, 24, 48, and 72 hours after initiation of intravenous loop diuretic therapy.
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Urinary sodium excretion measured at 6, 24, 48, and 72 hours after initiation of intravenous loop diuretic therapy.
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6, 24, 48, and 72 hours after initiation of intravenous loop diuretic therapy.
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Time to Clinical Decongestion
Délai: From initiation of intravenous loop diuretic therapy until clinical decongestion, assessed up to 14 days.
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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.
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From initiation of intravenous loop diuretic therapy until clinical decongestion, assessed up to 14 days.
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Length of Hospital Stay
Délai: From hospital admission to hospital discharge, assessed up to 30 days.
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Duration of hospitalization measured as the number of days from hospital admission to hospital discharge.
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From hospital admission to hospital discharge, assessed up to 30 days.
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Death or Heart Failure Rehospitalization Within 30 Days After Discharge
Délai: From hospital discharge through 30 days after discharge.
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Composite outcome of all-cause mortality or rehospitalization due to worsening heart failure occurring within 30 days after hospital discharge.
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From hospital discharge through 30 days after discharge.
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Cumulative Urine Output
Délai: From initiation of intravenous loop diuretic therapy through hospital discharge, assessed up to 14 days.
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Total urine output measured during hospitalization.
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From initiation of intravenous loop diuretic therapy through hospital discharge, assessed up to 14 days.
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Proportion of Patients Achieving Predefined Natriuresis Targets
Délai: Within 72 hours after initiation of intravenous loop diuretic therapy.
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Proportion of patients achieving predefined urinary sodium excretion targets according to the study treatment algorithm during the first 72 hours of hospitalization.
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Within 72 hours after initiation of intravenous loop diuretic therapy.
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Incidence of Symptomatic Hypotension
Délai: From randomization through hospital discharge, assessed up to 14 days.
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Occurrence of symptomatic hypotension during hospitalization.
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From randomization through hospital discharge, assessed up to 14 days.
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Clinically Significant Electrolyte Disturbances
Délai: From baseline through hospital discharge, assessed up to 14 days.
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Occurrence of clinically significant abnormalities in serum potassium or sodium during hospitalization.
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From baseline through hospital discharge, assessed up to 14 days.
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All-Cause In-Hospital Mortality
Délai: From randomization through hospital discharge, assessed up to 14 days.
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Death from any cause occurring during hospitalization.
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From randomization through hospital discharge, assessed up to 14 days.
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Nurgul Ablakimova, PhD, West Kazakhstan Marat Ospanov Medical University
- Directeur d'études: Vadim Medovchshikov, PhD, West Kazakhstan Marat Ospanov Medical University
- Chercheur principal: Anzhela Soloveva, candidate of medical sciences, I.M. Sechenov First Moscow State Medical University
- Chaise d'étude: Svetlana Rachina, doctor of medical sciences, I.M. Sechenov First Moscow State Medical University
- Chaise d'étude: Gaziza Smagulova, candidate of medical sciences, West Kazakhstan Marat Ospanov Medical University
- Chercheur principal: Ayagoz Meshitbayeva, West Kazakhstan Marat Ospanov Medical University
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
- 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.
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 juin 2026
Achèvement primaire (Estimé)
1 décembre 2027
Achèvement de l'étude (Estimé)
1 décembre 2027
Dates d'inscription aux études
Première soumission
27 mai 2026
Première soumission répondant aux critères de contrôle qualité
1 juin 2026
Première publication (Réel)
8 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
8 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
1 juin 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 13/2-19-38-7
- Order №13/2-19-38-7 (Autre subvention/numéro de financement: West Kazakhstan Marat Ospanov medical university)
Plan pour les données individuelles des participants (IPD)
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Description du régime 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.
Délai de partage 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.
Critères d'accès au partage 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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .