EUCTR2018-001345-14-BE进行中（未招募）1 期
A multi-center, randomized, double-blind, phase IV clinical trial on the diuretic effects of Acetazolamide (Diamox ®) in patients with Decompensated heart failure and Volume OveRload. - Acetazolamide (Diamox ®) in Decompensated heart failure with Volume OveRload (ADVOR)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 519
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- An elective or emergency hospital admission with clinical diagnosis of ADHF and at least one clinical sign of volume overload (e.g. oedema, ascites or pleural effusion)
- •- Maintenance therapy with oral loop diuretics at a dose of at least 1 mg bumetanide or 40 mg furosemide or 20 mg torsemide for at least 1 month before hospital admission
- •- Plasma NT proBNP levels >1000 ng/mL or BNP levels >250 ng/mL at screening
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 129
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 390
排除标准
- •- Concurrent diagnosis of an acute coronary syndrome defined as typical chest pain in addition to a troponin rise above the 99th percentile and/or electrocardiographic changes suggestive of cardiac ischemia
- •- A previous or current diagnosis of hypertrophic, restrictive, or constrictive cardiomyopathy as documented in the medical record
- •- History of congenital heart disease requiring surgical correction
- •- History of cardiac transplantation and/or ventricular assist device
- •- Systolic blood pressure <90 mmHg or mean arterial pressure <65 mmHg at the moment of admission
- •- Expected use of intravenous inotropes, vasopressors or nitroprusside during the study. Use of nitrates is allowed only if the patient’s systolic blood pressure is >140 mmHg
- •- Estimated glomerular filtration rate (eGFR) <20 mL/min/1.73m² at screening
- •- Use of renal replacement therapy or ultrafiltration at any time before study inclusion
- •- Treatment with intravenous loop diuretics > 2 mg bumetanide during the index hospitalization before randomization
- •- Treatment with acetazolamide during the index hospitalization before randomization
- •- Exposure to nephrotoxic agents (i.e. contrast dye) anticipated within the next 3 days
- •- Use of any non-protocol defined diuretic agent with the exception of mineralocorticoid receptor antagonists. 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 upon study inclusion.
- •- Current use of sodium-glucose transporter 2 inhibitors
- •- Subjects who are pregnant or breastfeeding
研究者
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