Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Natriuresis With Acetazolamide or SGLT2 Inhibitors Added to Intravenous Loop Diuretics in Decompensated Heart Failure (GLIDE-DHF)

5 de novembro de 2026 atualizado por: Universidade do Porto

Natriuresis in Decompensated Heart Failure Patients Treated With Intravenous Loop Diuretics Alone or in Combination With an SGLT2 Inhibitor or Acetazolamide: a Single-Center, Prospective, Open-Label, Non-Randomized, Controlled Interventional Study (GLiflozin or AcetazolamIDE on Top of Loop Diuretics in Decompensated Heart Failure)

The GLIDE-DHF study compares the natriuretic effect of adding acetazolamide or a sodium-glucose co-transporter 2 inhibitor (SGLT2i) to intravenous loop diuretics, versus intravenous loop diuretics alone, in patients admitted to the emergency department with acute decompensated heart failure. Natriuresis is assessed by spot urinary sodium concentration measured 6 hours after the first study treatment. The study also evaluates changes in urinary and serum electrolytes, kidney function, blood pressure, clinical congestion and safety during the first 3 days of treatment.

Visão geral do estudo

Status

Ativo, não recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

68

Estágio

  • Fase 4

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

  • Portugal
    • Porto District
      • Porto, Porto District, Portugal, 4200-319
        • Unidade Local de Saúde São João

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

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Age ≥18 years
  • Admission to the emergency department with a primary diagnosis of decompensated heart failure
  • Inclusion within the first 24 hours after emergency department admission
  • In patients who received intravenous loop diuretics before inclusion, baseline urine sample collected at least 6 hours after the last loop diuretic dose
  • Written informed consent

Exclusion Criteria:

  • Hemodynamic instability (systolic blood pressure <90 mmHg and/or serum lactate >2 mmol/L)
  • Decompensated heart failure in the setting of an acute coronary syndrome
  • Chronic maintenance therapy with an SGLT2 inhibitor or acetazolamide before the current episode
  • Baseline estimated glomerular filtration rate (outside the acute episode) <20 mL/min/1.73 m²
  • Renal replacement therapy
  • Metabolic or respiratory acidosis (arterial pH <7.35)
  • Sodium bicarbonate administration before inclusion

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: Não randomizado
  • Modelo Intervencional: Atribuição sequencial
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Loop diuretic alone (LD)

Intravenous furosemide. Initial dose: twice the oral outpatient dose (maximum 160 mg IV), or 40 mg IV in patients not on chronic loop diuretics. Subsequent dose adjustments at the attending physician's discretion.
Medicamento: Furosemide

Intravenous furosemide; initial dose twice the oral outpatient dose (max 160 mg) or 40 mg if loop diuretic-naïve; subsequent adjustments per attending physician.
Experimental: Loop diuretic + SGLT2 inhibitor (LD+SGLT2i)

Intravenous furosemide (as in the LD arm) plus oral dapagliflozin 10 mg or empagliflozin 10 mg once daily, started on day 1. SGLT2i may be continued after day 3.
Medicamento: Furosemide

Intravenous furosemide; initial dose twice the oral outpatient dose (max 160 mg) or 40 mg if loop diuretic-naïve; subsequent adjustments per attending physician.

Medicamento: Dapagliflozin

Oral dapagliflozin 10 mg once daily.

Medicamento: Empagliflozin

Oral empagliflozin 10 mg once daily.
Experimental: Loop diuretic + acetazolamide (LD+A)

Intravenous furosemide (as in the LD arm) plus intravenous acetazolamide 500 mg once daily for a maximum of 3 days (maximum 3 administrations).
Medicamento: Furosemide

Intravenous furosemide; initial dose twice the oral outpatient dose (max 160 mg) or 40 mg if loop diuretic-naïve; subsequent adjustments per attending physician.

Medicamento: Acetazolamide

Intravenous acetazolamide 500 mg once daily for up to 3 days.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in spot urinary sodium concentration at 6 hours
Prazo: Baseline and 6 hours after the first study treatment administration (day 1)

Change in spot urinary sodium concentration (mmol/L) from baseline to 6 hours after the first study treatment administration. The main comparison is LD+A versus LD alone; the comparison of LD+SGLT2i versus LD alone is secondary.
Baseline and 6 hours after the first study treatment administration (day 1)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in spot urinary sodium concentration at day 3
Prazo: Baseline and 6 hours after the third study treatment administration (day 3)

Change in spot urinary sodium (mmol/L) from baseline to 6 hours after the third study treatment administration.
Baseline and 6 hours after the third study treatment administration (day 3)
Proportion of patients with spot urinary sodium >70 mmol/L
Prazo: 6 hours after first administration (day 1)

Percentage of patients achieving spot urinary sodium >70 mmol/L 6 hours after the first study treatment administration.
6 hours after first administration (day 1)
Change in spot urinary potassium
Prazo: Baseline, 6 hours after first administration (day 1) and 6 hours after third administration (day 3)

Change in spot urinary potassium (mmol/L) from baseline.
Baseline, 6 hours after first administration (day 1) and 6 hours after third administration (day 3)
Change in spot urinary magnesium
Prazo: Baseline, 6 hours after first administration (day 1) and 6 hours after third administration (day 3)

Change in spot urinary magnesium from baseline.
Baseline, 6 hours after first administration (day 1) and 6 hours after third administration (day 3)
Change in spot urinary phosphate
Prazo: Baseline, 6 hours after first administration (day 1) and 6 hours after third administration (day 3)

Change in spot urinary phosphate from baseline.
Baseline, 6 hours after first administration (day 1) and 6 hours after third administration (day 3)
Change in estimated glomerular filtration rate (eGFR)
Prazo: Baseline and day 3

Change in eGFR (mL/min/1.73 m²) from baseline.
Baseline and day 3
Change in hemoglobin
Prazo: Baseline and day 3

Change in hemoglobin (g/dL) from baseline.
Baseline and day 3
Change in hematocrit
Prazo: Baseline and day 3

Change in hematocrit (%) from baseline.
Baseline and day 3
Change in serum urea
Prazo: Baseline and day 3

Change in serum urea (mg/dL) from baseline.
Baseline and day 3
Change in serum sodium
Prazo: Baseline and day 3

Change in serum sodium (mmol/L) from baseline.
Baseline and day 3
Change in serum potassium
Prazo: Baseline and day 3

Change in serum potassium (mmol/L) from baseline.
Baseline and day 3
Change in serum chloride
Prazo: Baseline and day 3

Change in serum chloride (mmol/L) from baseline.
Baseline and day 3
Change in systolic blood pressure
Prazo: Baseline, day 2 and day 3

Change in systolic blood pressure (mmHg) from baseline.
Baseline, day 2 and day 3
Change in diastolic blood pressure
Prazo: Baseline, day 2 and day 3

Change in diastolic blood pressure (mmHg) from baseline.
Baseline, day 2 and day 3
Change in clinical congestion score
Prazo: Baseline, day 2 and day 3

Change in the clinical congestion score from baseline. The clinical congestion score is a composite score based on three items (orthopnea, peripheral edema and jugular venous pressure elevation), each graded from 0 to 3, with a total score ranging from 0 (no congestion) to 9 (maximum congestion). Higher scores indicate a worse outcome (more congestion).
Baseline, day 2 and day 3
Proportion of patients with clinical decongestion
Prazo: Day 3

Percentage of patients achieving clinical decongestion, defined as a clinical congestion score ≤2 points. The clinical congestion score is a composite score based on orthopnea, peripheral edema and jugular venous pressure elevation, each graded from 0 to 3 (total score 0-9; higher scores indicate more congestion).
Day 3
Cumulative intravenous loop diuretic dose
Prazo: Up to day 3

Cumulative intravenous furosemide dose (mg) administered up to day 3.
Up to day 3
Incidence of hypokalemia
Prazo: Baseline to day 3

Percentage of patients with serum potassium <3.5 mmol/L.
Baseline to day 3
Incidence of severe hypokalemia
Prazo: Baseline to day 3

Percentage of patients with serum potassium <3.0 mmol/L.
Baseline to day 3
Incidence of hyponatremia
Prazo: Baseline to day 3

Percentage of patients with serum sodium <135 mmol/L.
Baseline to day 3
Incidence of hypotension
Prazo: Baseline to day 3

Percentage of patients with systolic blood pressure <90 mmHg.
Baseline to day 3
Incidence of stage 2 acute kidney injury
Prazo: Baseline to day 3

Percentage of patients with stage 2 acute kidney injury according to the Kidney Disease: Improving Global Outcomes (KDIGO) staging criteria, defined as at least doubling of serum creatinine from baseline. KDIGO stages range from 1 to 3, with higher stages indicating more severe kidney injury (worse outcome).
Baseline to day 3
Incidence of ≥50% increase in serum creatinine
Prazo: Baseline to day 3

Percentage of patients with ≥50% increase in serum creatinine from baseline.
Baseline to day 3

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Length of hospital stay
Prazo: From emergency department admission until hospital discharge, assessed up to 90 days

Duration of index hospitalization (days).
From emergency department admission until hospital discharge, assessed up to 90 days
In-hospital mortality
Prazo: From emergency department admission until hospital discharge, assessed up to 90 days

Death from any cause during index hospitalization.
From emergency department admission until hospital discharge, assessed up to 90 days
All-cause mortality
Prazo: From study inclusion until death from any cause, assessed up to 90 days

Time to death from any cause.
From study inclusion until death from any cause, assessed up to 90 days
Cardiovascular mortality
Prazo: From study inclusion until cardiovascular death, assessed up to 90 days

Time to cardiovascular death.
From study inclusion until cardiovascular death, assessed up to 90 days
All-cause rehospitalization
Prazo: From hospital discharge until first rehospitalization for any cause, assessed up to 90 days after study inclusion

Time to first rehospitalization for any cause.
From hospital discharge until first rehospitalization for any cause, assessed up to 90 days after study inclusion
Heart failure rehospitalization
Prazo: From hospital discharge until first rehospitalization for heart failure, assessed up to 90 days after study inclusion

Time to first rehospitalization for heart failure.
From hospital discharge until first rehospitalization for heart failure, assessed up to 90 days after study inclusion
Composite of all-cause mortality or all-cause rehospitalization
Prazo: From study inclusion until the first occurrence of any component event, assessed up to 90 days

Time to first occurrence of all-cause death or all-cause rehospitalization.
From study inclusion until the first occurrence of any component event, assessed up to 90 days
Composite of cardiovascular mortality or heart failure rehospitalization
Prazo: From study inclusion until the first occurrence of any component event, assessed up to 90 days

Time to first occurrence of cardiovascular death or heart failure rehospitalization.
From study inclusion until the first occurrence of any component event, assessed up to 90 days

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Universidade do Porto

Investigadores

  • Investigador principal: Pedro M. Marques, MD, Unidade Local de Saúde São João, Oporto

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 (Real)

11 de março de 2024

Conclusão Primária (Real)

29 de setembro de 2026

Conclusão do estudo (Estimado)

1 de dezembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

29 de outubro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

5 de novembro de 2026

Primeira postagem (Real)

9 de novembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

9 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

5 de novembro de 2026

Última verificação

1 de outubro de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • GLIDE-DHF

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 .

Se inscrever