ISRCTN13587185已完成4 期
This study examines whether in hemodialysis patients with intradialytic hypertension (P) a single or weekly administration of irbesartan or nebivolol (I) compared to no drug administration (C) reduces peridialytic, intradialytic and ambulatory BP levels, as well as ambulatory arterial stiffness parameters (O).
Aristotle University of Thessaloniki School of Medicine0 个研究点目标入组 38 人开始时间: 2018年4月17日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
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
- 性别
- All
入选标准
- •1. Adult aged >18 years
- •2. End-stage renal disease treated with thrice-weekly maintenance hemodialysis for more than 3 months
- •3. Intradialytic hypertension (defined as mean intradialytic rise =10 mmHg in systolic BP in at least 4 over 6 consecutive hemodialysis sessions)
排除标准
- •1. Existing comorbidity requiring treatment with a RAS-blocker (i.e. heart failure, acute myocardial infraction e.t.c.)
- •2. Existing comorbidity requiring treatment with a ß-blocker (i.e. heart failure, cardiac arrhythmia, acute myocardial infarction, angina pectoris, etc.)
- •3. Existing specific contraindications to receive a RAS-blocker (i.e. history of hyperkalemia, angioedema, anaphylactic or allergic reaction)
- •4. Existing specific contraindications to receive a ß-blocker (bradyarrhythmia, chronic obstructive pulmonary disease, asthma, history of anaphylactic or allergic reaction)
- •5. Antihypertensive treatment with RAS-blockers (angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers or renin-inhibitor) or ß-blockers in a period less than one month prior to study enrollment.
- •6. Pre- or post-hemodialysis SBP levels <130mmHg in 4 out of 6 sessions during the two weeks of the diagnosis of intradialytic hypertension
- •7. Nonfunctional arteriovenous fistula in the contralateral arm of the one used as vascular access for the hemodialysis session that could interfere with proper ABPM recordings.
- •8. Active malignant disease or other advanced comorbidity resulting in particularly poor prognosis
- •9. Inability to understand and provide a written informed consent to participate in the study
研究者
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