Diastolic Dysfunction, Microcirculation Disturbance, Sympathetic Activation and Inflammation in Moderate Kidney Failure and in Diabetic Nephropathy: Disease Modification With Vitamin-D Receptor Activation. A Double-blind, Placebo-controlled, Randomised Trial - the SOLID Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- A significant reduction in muscle sympathetic nerve activity (MSNA) measured by means of microneurography.
研究概览
简要总结
To investigate whether treatment with a vitamin-D receptor activator is able to improve important markers of cardiovascular risk.
详细描述
Main question:
May 12 weeks of VDRA treatment reduce the pathological sympathetic overactivation associated with moderate kidney disease?
Secondary questions aim to thrown light on how VDRAs can reduce albuminuria and CRP, i.e. does VDRA treatment improve (prespecified statistical analyses):
A) diastolic dysfunction? B) capillary microcirculation, and whether ameliorated disturbances relate to improved diastolic dysfunction? C) endothelial dysfunction and arterial stiffness? D) inflammatory activation? E) platelet function and haemostasis? F) levels of antibacterial peptides? G) levels of IGFBP-1 and adiponectin?
Overall design The study is designed as a double-blind, randomised, placebo-controlled trial involving two groups (n=72) of patients: 1) chronic kidney failure (CKD, eGFR 15-59 mL/m2) and 2) chronic kidney failure and concomitant diabetes mellitus (CKD+DM).
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •eGFR 15-59 ml/m2
排除标准
- •Current vitamin D treatment
研究组 & 干预措施
Paricalcitol 2 microgram/d
干预措施: Zemplar (Drug)
Placebo
干预措施: Zemplar (Drug)
Paricalcitol 1 microgram/d
干预措施: Zemplar (Drug)
结局指标
主要结局
A significant reduction in muscle sympathetic nerve activity (MSNA) measured by means of microneurography.
时间窗: Measured after 12 weeks treatment.
Sympathetic activation is closely related to severity and progression of cardiovascular diseases, and renovascular dysfunction. We will directly measure sympathetic activation using microneurography (muscle sympathetic nerve activity; MSNA), expressed as bursts/minute and bursts/100 RR-interval. As this is a physiological study, the primary outcome will constitute a significant reduction in MSNA.
次要结局
- Microcirculatory function measured by laser doppler methods.(Measured after 12 weeks treatment.)
研究者
Jonas Spaak
MD, PhD
Danderyd Hospital