Phase II Trial to Evaluate the Efficacy and Safety of Spironolactone in Hemodialysis Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 3
- 主要终点
- Left Ventricular Mass Index
研究概览
简要总结
End stage renal disease (ESRD) patients exhibit an extraordinarily high annual mortality. Cardiovascular (CV) causes account for almost half of all-cause mortality. Increased left ventricular mass (LVM) is a common finding in ESRD patients on dialysis and is an independent predictor of survival. Yet, to date there is no established medical treatment to reduce CV morbidity and mortality in ESRD patients on hemodialysis. Blockade of aldosterone action by means of mineralocorticoid receptor antagonists (MRA) provides cardioprotection and improves outcome in heart failure patients. Furthermore, the MRA spironolactone has recently been shown to reduce LVM in patients with mild-to-moderate chronic kidney disease (CKD). The investigators here hypothesize that spironolactone treatment is cardioprotective by reducing LVM in ESRD patients on dialysis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age >18 years
- •Hemodialysis treatment for at least 3 months
- •At least 3 dialysis sessions per week
- •Written informed consent
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
研究组 & 干预措施
Spironolactone
干预措施: Spironolactone (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Left Ventricular Mass Index
时间窗: 9 months
as assessed by cardiac MRI
次要结局
- Vascular function(9 months)
- Clinical measures of heart failure severity(9 months)
- Office and 24h blood pressure(9 months)
- Cardiac function parameters(9 months)
- Quality of Life - Hospital Anxiety and Depression Scale (HADS)(9 months)
- Cardiac death and/or hospitalization for heart failure(9 months)
- Quality of Life - Kidney Disease Quality of Life Instrument (KDQOL-SF36)(9 months)
- Biomarkers of heart failure, inflammation and fibrosis(9 months)
- Safety measures(9 months)