Prasad Bhanu, St Onge Jennifer Rose, McCarron Michelle C E, Goyal Kunal, Dehghani Payam
Section of Nephrology, Department of Medicine, Regina Qu'Appelle Health Region, Saskatchewan, Canada.
Research and Performance Support, Regina Qu'Appelle Health Region, Saskatchewan, Canada.
Can J Kidney Health Dis. 2017 Jul 12;4:2054358117719028. doi: 10.1177/2054358117719028. eCollection 2017.
Central aortic blood pressures and arterial stiffness are better indicators of cardiovascular outcomes than brachial blood pressures. However, their response to renal denervation (RDN) in patients with stage 3 and stage 4 chronic kidney disease (CKD) has not yet been examined.
To evaluate the impact of RDN on central blood pressures, brachial (office and ambulatory) blood pressures, arterial stiffness, glomerular filtration rate (GFR), 24-hour urine protein, and selective cardiac parameters observed on echocardiograms.
Single-center, single-arm with pre-RDN/post-RDN follow-up.
Patients are being recruited from the multidisciplinary CKD clinic.
Fifty consecutive patients with stage 3 or stage 4 CKD and resistant hypertension, with no radiological or laboratory evidence of secondary causes of hypertension.
The key measurements are central blood pressures, pulse wave velocity, ambulatory 24-hour blood pressure, office blood pressures on BP Tru, GFR, 24-hour urine protein and sodium, blood pressure medication, and doses.
For our primary outcome, we will compare changes in central blood pressures from baseline to 6 months post RDN using a paired test or Mann-Whitney test. Secondary outcomes will examine changes in central blood pressures from baseline to 3, 12, 18, and 24 months post RDN as well as changes in office pressures, GFR, 24-hour urine protein and sodium, and medications at all time points using mixed-model analyses of variance or Friedman test. Multiple regression may be used to control for potential covariates.
Single-center study, with no sham arm.
Aortic blood pressure, rather than brachial blood pressure, optimally reflects the load placed on the left ventricle. Aortic blood pressure is also better associated with cardiovascular outcomes. If our study shows a preferential decrease in central blood pressures and improvements in cardiac parameters on echocardiograms post RDN, this may influence the way in which blood pressures are managed in clinics and offices.
ClinicalTrials.gov (NCT01832233).
与肱动脉血压相比，中心主动脉血压和动脉僵硬度是心血管疾病预后的更好指标。然而，3期和4期慢性肾脏病（CKD）患者对肾去神经支配（RDN）的反应尚未得到研究。
评估RDN对中心血压、肱动脉（诊室和动态）血压、动脉僵硬度、肾小球滤过率（GFR）、24小时尿蛋白以及超声心动图观察到的选择性心脏参数的影响。
单中心、单臂，RDN术前/术后随访。
从多学科CKD诊所招募患者。
50例连续的3期或4期CKD合并顽固性高血压患者，无高血压继发原因的影像学或实验室证据。
关键测量指标为中心血压、脉搏波速度、动态24小时血压、BP Tru上的诊室血压、GFR、24小时尿蛋白和钠、血压药物及剂量。
对于我们的主要结局，我们将使用配对t检验或Mann-Whitney检验比较RDN术后6个月中心血压相对于基线的变化。次要结局将使用方差混合模型分析或Friedman检验，检查RDN术后3、12、18和24个月中心血压相对于基线的变化，以及所有时间点的诊室血压、GFR、24小时尿蛋白和钠以及药物的变化。可能会使用多元回归来控制潜在的协变量。
单中心研究，无假手术组。
主动脉血压而非肱动脉血压能最佳地反映左心室所承受的负荷。主动脉血压也与心血管疾病预后有更好的相关性。如果我们的研究显示RDN术后中心血压优先降低且超声心动图上的心脏参数得到改善，这可能会影响临床和诊室中血压的管理方式。
ClinicalTrials.gov（NCT01832233）。
