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

5. november 2026 oppdatert 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.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

68

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / 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.
Legemiddel: 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.
Eksperimentell: 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.
Legemiddel: 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.

Legemiddel: Dapagliflozin

Oral dapagliflozin 10 mg once daily.

Legemiddel: Empagliflozin

Oral empagliflozin 10 mg once daily.
Eksperimentell: 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).
Legemiddel: 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.

Legemiddel: Acetazolamide

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in spot urinary sodium concentration at 6 hours
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in spot urinary sodium concentration at day 3
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: Baseline and day 3

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

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

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

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

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

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

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

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

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

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

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

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

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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Length of hospital stay
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Universidade do Porto

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

11. mars 2024

Primær fullføring (Faktiske)

29. september 2026

Studiet fullført (Antatt)

1. desember 2026

Datoer for studieregistrering

Først innsendt

29. oktober 2026

Først innsendt som oppfylte QC-kriteriene

5. november 2026

Først lagt ut (Faktiske)

9. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. november 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • GLIDE-DHF

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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