EUCTR2011-003179-12-DE进行中（未招募）1 期
Mineralocorticoid Receptor antagonists in End stage reNal DiseAse - MiREnDa
niversity Hospital of Wuerzburg, Medical Director0 个研究点开始时间: 2011年9月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •Written informed consent
- •Age > 18 years
- •Hemodialysis treatment for at least 3 months
- •At least 3 dialysis sessions per week
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •Contraindications for cardiac magnet resonance imaging (CMR)
- •Mineralocorticoid receptor antagonist treatment within the last 6 months
- •Estimated life expectancy < 12 months as judged by the nephrologist
- •History of hyperkalemia, defined as pre-dialysis potassium > 6.5 mmol/l occurring = 3 times within the last 3 months prior to enrolment
- •High risk to develop hyperkalemia defined as pre-dialysis potassium > 6.0 mmol/l
- •Hypotension (systolic blood pressure < 100 mmHg)
- •Planned kidney transplantation (living donor) within the prospected study duration
- •Any acute illness within the last 4 weeks precluding a study participation as judged by the nephrologist
- •Non-amenorrheic women with child bearing potential without reliable contraception, pregnancy/lactation
- •Allergy/hypersensitivity to spironolactone
- •Non-compliance suspected or demonstrated
研究者
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