JPRN-jRCT1031230599招募中2 期
An open-label, single arm, multicenter study to evaluate the safety and efficacy of sacubitril valsartan in patients with chronic heart failure on hemodialysis
Asanuma Katsuhiko0 个研究点目标入组 32 人开始时间: 2024年1月26日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Japanese patients 18 years of age or older at the time of consent
- •2) Patients undergoing hemodialysis
- •3) Patients with a pre-dialysis hemoglobin concentration of 8.0 g/dL or higher
- •4) Patients diagnosed with New York Heart Association (NYHA) cardiac function class I-III chronic heart failure and left ventricular ejection fraction less than 50%
- •5) Patients who have received a thorough explanation of the study and who have given written consent of their own free will after full understanding of the study
排除标准
- •1) Patients with acute noncompensated heart failure (exacerbation of chronic heart failure with obvious signs and symptoms that require intravenous administration of drugs for heart failure)
- •2) Patients with a history of angioedema (angioedema caused by angiotensin II receptor blockers or angiotensin converting enzyme inhibitors, hereditary angioedema, acquired angioedema, idiopathic angioedema, etc.)
- •3) Patients receiving angiotensin-converting enzyme inhibitors or within 36 hours of discontinuation of angiotensin-converting enzyme inhibitors
- •4) Patients with symptomatic hypotension
- •5) Diabetic patients receiving aliskiren fumarate
- •6) Patients with severe anemia (received blood transfusion within 4 weeks prior to obtaining consent)
- •7) Patients with severe hepatic dysfunction (Child-Pugh classification C or alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels greater than 100 IU/L)
- •8) Patients with cerebrovascular disease
- •9) Patients with hyperkalemia (serum K level of 5.5 mEq/L or higher) in the past 3 months
- •10) Patients with a history of severe allergy to drugs
- •11) Patients with drug or alcohol addiction or with a history of drug or alcohol addiction
- •12) Patients who have received sacubitril valsartan sodium hydrate in the past
- •13) Patients who are pregnant, possibly pregnant, within 28 days postpartum, or lactating
- •14) Other patients whom the investigator or sub-investigator determines to be unsuitable for the safe conduct of this study
研究者
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