SURE-HF: Urinary Sodium-Guided Diuretic Therapy in Heart Failure (SURE-HF)
1 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
260
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Aktobe, Kazajstán, 030000
- West Kazakhstan Marat Ospanov Medical University
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Contacto:
- Ayagoz Meshitbayeva
- Número de teléfono: 77714040296
- Correo electrónico: ayagozmeshitbayeva@gmail.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: 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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Experimental: 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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Experimental: 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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Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Hierarchical Composite Endpoint of Unsuccessful Decongestion
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Total and Time-Specific Urinary Sodium Excretion
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Incidence of Symptomatic Hypotension
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Nurgul Ablakimova, PhD, West Kazakhstan Marat Ospanov Medical University
- Director de estudio: Vadim Medovchshikov, PhD, West Kazakhstan Marat Ospanov Medical University
- Investigador principal: Anzhela Soloveva, candidate of medical sciences, I.M. Sechenov First Moscow State Medical University
- Silla de estudio: Svetlana Rachina, doctor of medical sciences, I.M. Sechenov First Moscow State Medical University
- Silla de estudio: Gaziza Smagulova, candidate of medical sciences, West Kazakhstan Marat Ospanov Medical University
- Investigador principal: Ayagoz Meshitbayeva, West Kazakhstan Marat Ospanov Medical University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de junio de 2026
Finalización primaria (Estimado)
1 de diciembre de 2027
Finalización del estudio (Estimado)
1 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
27 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
1 de junio de 2026
Publicado por primera vez (Actual)
8 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
1 de junio de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 13/2-19-38-7
- Order №13/2-19-38-7 (Otro número de subvención/financiamiento: West Kazakhstan Marat Ospanov medical university)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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.
Marco de tiempo para compartir 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.
Criterios de acceso compartido de 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 de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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