Natriuresis With Acetazolamide or SGLT2 Inhibitors Added to Intravenous Loop Diuretics in Decompensated Heart Failure (GLIDE-DHF)
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.
調査の概要
状態
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Porto District
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Porto、Porto District、ポルトガル、4200-319
- Unidade Local de Saúde São João
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：順次割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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. |
Intravenous furosemide; initial dose twice the oral outpatient dose (max 160 mg) or 40 mg if loop diuretic-naïve; subsequent adjustments per attending physician. |
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実験的：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. |
Intravenous furosemide; initial dose twice the oral outpatient dose (max 160 mg) or 40 mg if loop diuretic-naïve; subsequent adjustments per attending physician. Oral dapagliflozin 10 mg once daily. Oral empagliflozin 10 mg once daily. |
|
実験的：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). |
Intravenous furosemide; initial dose twice the oral outpatient dose (max 160 mg) or 40 mg if loop diuretic-naïve; subsequent adjustments per attending physician. Intravenous acetazolamide 500 mg once daily for up to 3 days. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in spot urinary sodium concentration at 6 hours
時間枠：Baseline and 6 hours after the first study treatment administration (day 1)
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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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in spot urinary sodium concentration at day 3
時間枠：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)
|
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Proportion of patients with spot urinary sodium >70 mmol/L
時間枠：6 hours after first administration (day 1)
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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)
|
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Change in spot urinary potassium
時間枠：Baseline, 6 hours after first administration (day 1) and 6 hours after third administration (day 3)
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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)
|
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Change in spot urinary magnesium
時間枠：Baseline, 6 hours after first administration (day 1) and 6 hours after third administration (day 3)
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Change in spot urinary magnesium from baseline. |
Baseline, 6 hours after first administration (day 1) and 6 hours after third administration (day 3)
|
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Change in spot urinary phosphate
時間枠：Baseline, 6 hours after first administration (day 1) and 6 hours after third administration (day 3)
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Change in spot urinary phosphate from baseline. |
Baseline, 6 hours after first administration (day 1) and 6 hours after third administration (day 3)
|
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Change in estimated glomerular filtration rate (eGFR)
時間枠：Baseline and day 3
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Change in eGFR (mL/min/1.73 m²) from baseline. |
Baseline and day 3
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Change in hemoglobin
時間枠：Baseline and day 3
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Change in hemoglobin (g/dL) from baseline. |
Baseline and day 3
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Change in hematocrit
時間枠：Baseline and day 3
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Change in hematocrit (%) from baseline. |
Baseline and day 3
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Change in serum urea
時間枠：Baseline and day 3
|
Change in serum urea (mg/dL) from baseline. |
Baseline and day 3
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Change in serum sodium
時間枠：Baseline and day 3
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Change in serum sodium (mmol/L) from baseline. |
Baseline and day 3
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Change in serum potassium
時間枠：Baseline and day 3
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Change in serum potassium (mmol/L) from baseline. |
Baseline and day 3
|
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Change in serum chloride
時間枠：Baseline and day 3
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Change in serum chloride (mmol/L) from baseline. |
Baseline and day 3
|
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Change in systolic blood pressure
時間枠：Baseline, day 2 and day 3
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Change in systolic blood pressure (mmHg) from baseline. |
Baseline, day 2 and day 3
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Change in diastolic blood pressure
時間枠：Baseline, day 2 and day 3
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Change in diastolic blood pressure (mmHg) from baseline. |
Baseline, day 2 and day 3
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Change in clinical congestion score
時間枠：Baseline, day 2 and day 3
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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
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Proportion of patients with clinical decongestion
時間枠：Day 3
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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
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Cumulative intravenous loop diuretic dose
時間枠：Up to day 3
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Cumulative intravenous furosemide dose (mg) administered up to day 3. |
Up to day 3
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Incidence of hypokalemia
時間枠：Baseline to day 3
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Percentage of patients with serum potassium <3.5 mmol/L. |
Baseline to day 3
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Incidence of severe hypokalemia
時間枠：Baseline to day 3
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Percentage of patients with serum potassium <3.0 mmol/L. |
Baseline to day 3
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Incidence of hyponatremia
時間枠：Baseline to day 3
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Percentage of patients with serum sodium <135 mmol/L. |
Baseline to day 3
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Incidence of hypotension
時間枠：Baseline to day 3
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Percentage of patients with systolic blood pressure <90 mmHg. |
Baseline to day 3
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Incidence of stage 2 acute kidney injury
時間枠：Baseline to day 3
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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
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Incidence of ≥50% increase in serum creatinine
時間枠：Baseline to day 3
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Percentage of patients with ≥50% increase in serum creatinine from baseline. |
Baseline to day 3
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Length of hospital stay
時間枠：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
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In-hospital mortality
時間枠：From emergency department admission until hospital discharge, assessed up to 90 days
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Death from any cause during index hospitalization. |
From emergency department admission until hospital discharge, assessed up to 90 days
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All-cause mortality
時間枠：From study inclusion until death from any cause, assessed up to 90 days
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Time to death from any cause. |
From study inclusion until death from any cause, assessed up to 90 days
|
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Cardiovascular mortality
時間枠：From study inclusion until cardiovascular death, assessed up to 90 days
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Time to cardiovascular death. |
From study inclusion until cardiovascular death, assessed up to 90 days
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All-cause rehospitalization
時間枠：From hospital discharge until first rehospitalization for any cause, assessed up to 90 days after study inclusion
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Time to first rehospitalization for any cause. |
From hospital discharge until first rehospitalization for any cause, assessed up to 90 days after study inclusion
|
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Heart failure rehospitalization
時間枠：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
|
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Composite of all-cause mortality or all-cause rehospitalization
時間枠：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
|
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Composite of cardiovascular mortality or heart failure rehospitalization
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Pedro M. Marques, MD、Unidade Local de Saúde São João, Oporto
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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