Prasad Bhanu, Berry Warren, Goyal Kunal, Dehghani Payam, Townsend Raymond R
Section of Nephrology, Department of Medicine, Regina General Hospital, SK, Canada.
Research and Performance Support, Wascana Hospital, Regina, SK, Canada.
Can J Kidney Health Dis. 2019 Feb 13;6:2054358119828388. doi: 10.1177/2054358119828388. eCollection 2019.
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 (CBP), 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-/post-RDN follow-up.
Patients were recruited from the multidisciplinary CKD clinic, Regina General Hospital, Canada.
About 25 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 were CBP, pulse wave velocity, ambulatory 24-hour blood pressure, office blood pressures on BP Tru, GFR, 24-hour urine protein and sodium, dose and number of blood pressure medication and doses.
The primary outcome measure was the change in CBP from baseline to 6 months post-RDN. Secondary outcome measures included changes in CBP, office blood pressure, 24-hour ambulatory pressures, pulse wave velocity, kidney function (eGFR and 24-hour protein excretion), and the change in the number and dose of medications during the 2-year follow-up period. The primary outcome and the secondary outcomes were evaluated using a Friedman's analysis of variance (ANOVA) and Wilcoxon signed-rank test for changes from post RDN procedure. Bonferroni correction was used to adjust values for multiple testing. A two-sided alpha of .05 was used.
Median central blood pressures (mm Hg) were 127/75 at baseline versus 118/70 at 6 months and 118/67 at 24 months ( = .13). Median office blood pressures (mm Hg) were 148/76 at baseline versus 135/75 at 6 months and 133/75 at 24 months ( ≤ .001). Median ambulatory 24-hour day (mm Hg) was 148/64 at baseline and 146/68 at 6 months and 152/67 at 24 months ( = .60). Median pulse wave velocity (m/s) at baseline was 13.8 at baseline versus 13.3 m/s at 6 months and 12.3 at 12 months' time ( = .62). Estimated glomerular filtration rate (mL/min/1.73m) at baseline was 37, at 6 months was 36 and 34 at 24 months ( = .33).
Single-center study, with no sham arm.
Our study demonstrates that there was a significant improvement in office blood pressures from baseline to 6 months, maintained to 24 months. There was a numerical improvement in central pressures, and pulse wave velocity at 6 and 24 months, with no sustained changes noted in 24-hour blood pressure. Kidney function remained at or near baseline throughout the 24 months of observation.
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,尚未对3期和4期慢性肾脏病(CKD)患者进行肾去神经支配(RDN)治疗后中心主动脉血压和动脉僵硬度的变化进行研究。
评估RDN对中心血压(CBP)、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前后随访研究。
患者来自加拿大里贾纳综合医院多学科CKD诊所。
约25例连续性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。
主要测量指标为CBP、脉搏波速度、动态24小时血压、BP Tru诊室血压、GFR、24小时尿蛋白和尿钠、血压药物剂量和数量。
主要结局指标为RDN术后6个月CBP相对于基线的变化。次要结局指标包括2年随访期内CBP、诊室血压、24小时动态血压、脉搏波速度、肾功能(估算肾小球滤过率和24小时蛋白排泄量)的变化,以及药物数量和剂量的变化。主要结局和次要结局采用Friedman方差分析(ANOVA)和Wilcoxon符号秩检验评估RDN术后的变化。采用Bonferroni校正对多重检验的P值进行调整。双侧α水平设定为0.05。
基线时中心血压中位数(mmHg)为127/75,6个月时为118/70,24个月时为118/67(P = 0.13)。诊室血压中位数(mmHg)基线时为148/76,6个月时为135/75,24个月时为133/75(P≤0.001)。动态24小时血压中位数(mmHg)基线时为148/64,6个月时为146/68,24个月时为152/67(P = 0.60)。基线时脉搏波速度中位数(m/s)为13.8,6个月时为13.3 m/s,12个月时为12.3(P = 0.62)。估算肾小球滤过率(mL/min/1.73m²)基线时为37,6个月时为36,24个月时为34(P = 0.33)。
单中心研究,无假手术组。
我们的研究表明,从基线到6个月诊室血压有显著改善,并持续至24个月。6个月和24个月时中心血压和脉搏波速度有数值上的改善,24小时血压无持续变化。在24个月的观察期内,肾功能维持在基线水平或接近基线水平。
ClinicalTrials.gov(NCT01832233)