NL-OMON55957
尚未招募
不适用
Safety and Efficacy of Ultrasound Renal Denervation in Kidney Transplantation Patients with Uncontrolled Hypertension: the RESTART Study - RESTART
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- high blood pressure
- 发起方
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- 入组人数
- 40
- 状态
- 尚未招募
- 最后更新
- 去年
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Age \>\= 18 years
- •2\. Kidney transplantation \>\= 12 months ago with stable immunosuppressive drug
- •treatment (dosage changes to maintain a steady serum concentration are
- •3\. Estimated Glomerular Filtration Rate (eGFR) \>\= 40 ml/min/1\.73m2
- •4\. Office systolic blood pressure \>\= 140 mmHg at screening (V0\), and a systolic
- •mean 24\-hour ambulatory blood pressure \>\= 130 mmHg (V1\)
- •5\. With respect to antihypertensive medication:
- •a. Patients should be on a stable regimen of at least two antihypertensive
- •drugs of different classes, including a diuretic (defined a thiazide diuretic,
- •loop diuretic or mineralocorticoid receptor antagonist), for at least three
排除标准
- •Native renal artery anatomy not eligible for renale denervatie, defined as at least one of the following conditions: o History of renal artery stenting or angioplasty o History of renal denervation o History of kidney tumors o Renal artery diameter \< 3 mm or \> 8 mm o Renal artery length \< 20 mm o Fibromuscular disease (FMD) of the native renal arteries o Renal artery aneurysm o Renal artery stenosis \> 30% • Presence of a remnant transplant kidney after re\-transplantation or absence of native kidneys • Solitary native kidney • History of intravenous contrast dye allergy or nephropathy • Iliac/femoral artery stenosis precluding insertion of the Paradise catheter • Uncorrected, treatable secondary cause of hypertension • Pregnancy • Life expectancy \< one year at the discretion of the investigator
结局指标
主要结局
未指定
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