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

5 novembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

68

Phase

  • Phase 4

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

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

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

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

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: Non randomisé
  • Modèle interventionnel: Affectation séquentielle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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.
Médicament: 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.
Expérimental: 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.
Médicament: 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.

Médicament: Dapagliflozin

Oral dapagliflozin 10 mg once daily.

Médicament: Empagliflozin

Oral empagliflozin 10 mg once daily.
Expérimental: 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).
Médicament: 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.

Médicament: Acetazolamide

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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in spot urinary sodium concentration at 6 hours
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in spot urinary sodium concentration at day 3
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: Baseline and day 3

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

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

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

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

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

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

Change in serum chloride (mmol/L) from baseline.
Baseline and day 3
Change in systolic blood pressure
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Up to day 3

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

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

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

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

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

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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Length of hospital stay
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Universidade do Porto

Les enquêteurs

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

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 (Réel)

11 mars 2024

Achèvement primaire (Réel)

29 septembre 2026

Achèvement de l'étude (Estimé)

1 décembre 2026

Dates d'inscription aux études

Première soumission

29 octobre 2026

Première soumission répondant aux critères de contrôle qualité

5 novembre 2026

Première publication (Réel)

9 novembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 novembre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • GLIDE-DHF

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 .

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