NCT07023016已完成2 期
Comparative Assessment of Efficacy & Safety of Sacubitril/Valsartan Versus Ramipril in Patients With Renal Dysfunction Hospitalized With Acute Decompensated Heart Failure - CAESAR (a Randomized Controlled Trial)
National Heart Institute, Egypt2 个研究点 分布在 1 个国家目标入组 515 人开始时间: 2023年11月1日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 515
- 试验地点
- 2
- 主要终点
- Difference in mean eGFR (mL/min/1.73m2) between both groups at 12 weeks post-randomization.
研究概览
简要总结
Sacubitril/valsartan is an established medication for heart failure. However, data still lags in its use in heart failure patients with chronic kidney disease. Sacubitril/valsartan is manufacturer-labeled for use in patients with eGFR < 30 ml/min/1.73 m2 at an initial dose of 24/26mg twice daily. However, to the best of our knowledge, the concept of sacubitril/valsartan or ACEi in patients with chronic kidney disease & presenting with decompensated heart failure has not yet been explored fully.
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
- •All the following should be met:
- •Acute decompensated heart failure (ADHF)
- •Left ventricular ejection fraction (LVEF) below 40%
- •Renal dysfunction; defined as eGFR of 30mL/min/1.73m2 to less than 60mL/min/1.73m2 in relation to the level of urinary albumin/creatinine ratio (uACR) based on the 2024 Kidney Disease: Improving Global Outcomes (KDIGO) clinical practice guidelines for the evaluation and management of CKD.
- •A minimum blood pressure (BP) ≥ 105/60 mmHg.
- •Independent of any inotropic or vasopressor support in the previous 24 hours before inclusion and randomization.
- •No more than 72 hours had passed since admission to the heart failure unit.
- •Patients should have had a New York Heart Association (NYHA) functional class II-IV, in addition to symptoms of volume overload at the time of presentation to the emergency room.
排除标准
- •Patients who were on sacubitril/valsartan or ACEI/ angiotensin receptor blocker (ARB) before inclusion in the previous 12 months.
- •Patients with AKI on presentation OR in the last 3 months OR had ≥ 2 hospital admissions in the last 12 months for AKI.
- •History of known or suspected hypersensitivity, contraindications, or intolerance to any of the study drugs including ACEI, ARB or sacubitril (neprilysin inhibitor).
- •Requirement for double treatment with both ACEI and ARB.
- •Serum potassium (K+) level ≥ 5.0 mmol/L at randomization.
- •A recent major adverse cardiovascular/cerebrovascular event within 1 month (acute coronary syndrome, stroke, transient ischemic attack, etc.).
- •Patients with hemodynamically significant primary valvular lesion.
- •Known hepatic impairment with a model for end-stage liver disease (MELD) score >
- •History of malignancy of any organ system within the past year with a life expectancy < 1 year.
研究组 & 干预措施
Sacubitril / Valsartan
Experimental
干预措施: Sacubitril / Valsartan (Drug)
Ramipril
Active Comparator
干预措施: Ramipril (ACE-inhibitor) (Drug)
结局指标
主要结局
Difference in mean eGFR (mL/min/1.73m2) between both groups at 12 weeks post-randomization.
时间窗: 12 weeks
次要结局
- Number of patients in each group who develop worsening renal function throughout the study period.(12 weeks)
- Number of events in each group for hyperkalemia throughout the study period.(12 weeks)
- Number of events in each group for symptomatic hypotension throughout the study period.(12 weeks)
- Number of events in each group for angioedema throughout the study period.(12 weeks)
- Difference between uACR levels (gm/mg) in each group at 12 weeks post-randomization.(12 weeks)
- Difference between NT-proBNP levels (pg/mL) in each group at 12 weeks post-randomization(12 weeks)
- Difference between LVEF (%) of each group at 12 weeks post-randomization(12 weeks)
研究者
Omar Younis
Cardiology Researcher
National Heart Institute, Egypt
研究点 (2)
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