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

5 november 2026 uppdaterad av: 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.

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

68

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Sekventiell tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: 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.
Läkemedel: 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.
Experimentell: 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.
Läkemedel: 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.

Läkemedel: Dapagliflozin

Oral dapagliflozin 10 mg once daily.

Läkemedel: Empagliflozin

Oral empagliflozin 10 mg once daily.
Experimentell: 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).
Läkemedel: 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.

Läkemedel: Acetazolamide

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in spot urinary sodium concentration at 6 hours
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in spot urinary sodium concentration at day 3
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: Baseline and day 3

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

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

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

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

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

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

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

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

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

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

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

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

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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Length of hospital stay
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Universidade do Porto

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

11 mars 2024

Primärt slutförande (Faktisk)

29 september 2026

Avslutad studie (Beräknad)

1 december 2026

Studieregistreringsdatum

Först inskickad

29 oktober 2026

Först inskickad som uppfyllde QC-kriterierna

5 november 2026

Första postat (Faktisk)

9 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 november 2026

Senast verifierad

1 oktober 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • GLIDE-DHF

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