SURE-HF: Urinary Sodium-Guided Diuretic Therapy in Heart Failure (SURE-HF)
1 de junho de 2026 atualizado 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.
Visão geral do estudo
Status
Ainda não está recrutando
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
260
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Aktobe, Cazaquistão, 030000
- West Kazakhstan Marat Ospanov Medical University
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Contato:
- Ayagoz Meshitbayeva
- Número de telefone: 77714040296
- E-mail: ayagozmeshitbayeva@gmail.com
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Hierarchical Composite Endpoint of Unsuccessful Decongestion
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Total and Time-Specific Urinary Sodium Excretion
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
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Incidence of Symptomatic Hypotension
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Nurgul Ablakimova, PhD, West Kazakhstan Marat Ospanov Medical University
- Diretor de estudo: 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
- Cadeira de estudo: Svetlana Rachina, doctor of medical sciences, I.M. Sechenov First Moscow State Medical University
- Cadeira de estudo: Gaziza Smagulova, candidate of medical sciences, West Kazakhstan Marat Ospanov Medical University
- Investigador principal: Ayagoz Meshitbayeva, West Kazakhstan Marat Ospanov Medical University
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de junho de 2026
Conclusão Primária (Estimado)
1 de dezembro de 2027
Conclusão do estudo (Estimado)
1 de dezembro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
27 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
1 de junho de 2026
Primeira postagem (Real)
8 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
8 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
1 de junho de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 13/2-19-38-7
- Order №13/2-19-38-7 (Número de outro subsídio/financiamento: West Kazakhstan Marat Ospanov medical university)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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.
Prazo de Compartilhamento de 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.
Critérios de acesso de compartilhamento 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 informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .