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

5 november 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

68

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Geneesmiddel: 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.
Experimenteel: 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.
Geneesmiddel: 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.

Geneesmiddel: Dapagliflozin

Oral dapagliflozin 10 mg once daily.

Geneesmiddel: Empagliflozin

Oral empagliflozin 10 mg once daily.
Experimenteel: 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).
Geneesmiddel: 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.

Geneesmiddel: Acetazolamide

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in spot urinary sodium concentration at 6 hours
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in spot urinary sodium concentration at day 3
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: Baseline and day 3

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

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

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

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

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

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

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

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

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

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

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

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

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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Length of hospital stay
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Universidade do Porto

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

11 maart 2024

Primaire voltooiing (Werkelijk)

29 september 2026

Studie voltooiing (Geschat)

1 december 2026

Studieregistratiedata

Eerst ingediend

29 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

5 november 2026

Eerst geplaatst (Werkelijk)

9 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 november 2026

Laatste update ingediend die voldeed aan QC-criteria

5 november 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • GLIDE-DHF

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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