Acetazolamide Versus Dapagliflozin in Acute Decompensated Heart Failure Patients
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- N-terminal pro-B-type natriuretic peptide (NT-proBNP)
研究概览
简要总结
The goal of this clinical trial is to compare the effectiveness of acetazolamide versus dapagliflozin as an add-on in treating acute decompensated heart failure (ADHF) in adult patients with clinical signs of volume overload requiring intravenous loop diuretics. It will also assess the safety of these drugs when added to standard care. The main questions it aims to answer are:
- Does acetazolamide or dapagliflozin lead to a greater reduction in N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels?
- Which drug results in better loop diuretic efficiency, as measured by weight loss per 40 mg of intravenous furosemide or equivalent? We will compare acetazolamide to dapagliflozin, both added to standard intravenous loop diuretic therapy, to see which is more effective in decongesting patients with ADHF.
Participants will:
- Take either acetazolamide or dapagliflozin orally every day for 3 days
- Receive intravenous loop diuretics as part of standard care
- Undergo regular assessments of heart failure symptoms, weight, and laboratory tests
- Be followed up until hospital discharge and for 30 days after starting the study
详细描述
A. Study design
- Prospective, open-label, randomized, two-armed parallel comparator study.
- Participants recruited in the study must provide written informed consent after obtaining ethical approval from ethics committee.
B. Study settings Critical Care Medicine Department - Cairo University Hospitals. C. Population of study Adult patients who are admitted to Critical Care Medicine Department - Cairo University Hospitals because of acute decompensated heart failure will be screened for inclusion into the study. Patients who have at least one clinical sign of volume overload (i.e., edema, pleural effusion, or ascites) and ECHO-confirmed HF at screening will be included in the study.
D.Treatment :
I.V loop diuretics
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients of 18 years of age or older.
- •An elective or emergency hospital admission with clinical diagnosis of decompensated HF with at least one clinical sign of volume overload (e.g. edema, ascites confirmed by echography or pleural effusion confirmed by chest X-ray or echography).
- •Assessed LVEF by any imaging technique; i.e. echocardiography, catheterization, nuclear scan magnetic resonance imaging within 12 months of inclusion.
排除标准
- •The receipt of acetazolamide maintenance therapy.
- •Receipt of an SGLT2 inhibitor in the 48 hours before randomization.
- •An estimated glomerular filtration rate (eGFR) <20 mL/min/1.73 m
- •Use of any non-protocol defined diuretic agent with the exception of mineralocorticoid receptor antagonists during the treatment phase of the study. Thiazides, metolazone, indapamide and amiloride should be stopped upon study inclusion. If patient is taking a combination drug including a thiazide-type diuretic, the thiazide-type diuretic should be stopped.
研究组 & 干预措施
Acetazolamide + Standard Care
Participants in this arm will receive:
- Acetazolamide: 500 mg orally, once daily for 3 days
- Intravenous loop diuretics: Administered at double the oral maintenance dose, given as follows:
- Initial dose: Single bolus immediately after randomization
- Subsequent doses: Split into two or more doses (separated by ≥6 hours) on each of the next 2 days The specific loop diuretic used (e.g., furosemide) will be determined by the treating physician based on the patient's prior medication regimen and clinical status.
干预措施: Acetazolamide (Drug)
Dapagliflozin + Standard Care
Participants in this arm will receive:
- Dapagliflozin: 10 mg orally, once daily for 3 days
- Intravenous loop diuretics: Administered as described in Arm 1
干预措施: Dapagliflozin 10mg (Drug)
结局指标
主要结局
N-terminal pro-B-type natriuretic peptide (NT-proBNP)
时间窗: From baseline to day 5 or intensive care unit (ICU) discharge, whichever occurs first
Absolute change in NT-proBNP levels from baseline to end of study period
calculating of weight loss Loop diuretic efficiency
时间窗: 72 hours from initiation of treatment
Weight loss (in kg) per 40 mg of intravenous furosemide or equivalent dose of other loop diuretics
次要结局
- percent of worsening renal failure (WRF)(up to 4 weeks)
- Number of Participants with Successful decongestion(72 hours from initiation of treatment)
- Cumulative dose of intravenous loop diuretics(5 days)
- Duration of the index hospital admission(From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 100 weeks)
- 30-day mortality(Up to 30 days)
- Incidence of treatment-related metabolic acidosis(5 days)
研究者
Mahmoud I Mostafa
Lecturer of Clinical Pharmacy.Lecturer of Clinical Pharmacy, Faculty of Pharmacy, Helwan University, Cairo, Egypt.
Helwan University