RATIONALE & OBJECTIVE Optimal blood pressure (BP) targets in advanced CKD are controversial. More intensive BP lowering in the setting of advanced CKD is thought to be associated with risk of acute kidney injury, hyperkalemia, and ESKD. We aimed to conduct a pilot trial of intensive BP control to determine if lower SBP targets can be safely achieved for patients with CKD through titration of BP medications using in-home measured BP. STUDY DESIGN Non-blinded randomized controlled trial. SETTINGS & PARTICIPANTS 108 patients with advanced CKD (eGFR ≤30 mL/min/1.73 m2) and hypertension. INTERVENTIONS Participants were randomized either to a target home SBP goal of <120 mmHg (N=66) or a less intensive SBP goal (N=42). Antihypertensive medications were titrated to achieve the target home SBP range in the first 4 months of the study and maintained until the end of the study. Home BP was measured using a wireless Bluetooth-enabled monitor that transmitted readings to providers in real-time. OUTCOMES The primary efficacy outcome was the difference in achieved clinic SBP between the two study arms from months 4-12. Safety outcomes included hyperkalemia, a composite outcome of falls or syncope, and onset of need for dialysis or kidney transplantation. RESULTS The mean clinic SBP at month 12 was 124.7 mmHg in the intensive SBP group vs. 138.2 mmHg in the less intensive SBP group. Averaged over months 4-12, the achieved mean clinic SBP in the intensive SBP arm was 11.7 mmHg (95% CI 7.5 to 16 mmHg, p<0.001) lower than the mean SBP achieved in the less intensive SBP arm. Primary safety outcomes were not statistically significantly different between the two arms (all p>0.05). LIMITATIONS Small sample size which may limit our ability to detect clinically significant differences in rates of adverse outcomes; single-center design. CONCLUSIONS A clinic SBP goal of <120 mmHg is feasible to achieve with the help of real-time home BP monitoring and appears to be safe in this study population with advanced CKD. Larger trials to determine optimal BP targets in advanced CKD and the risks and benefits associated with more intensive BP control are warranted.

中文翻译：

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晚期 CKD 患者的强化家庭血压降低。


基本原理和目标 晚期慢性肾病的最佳血压（BP）目标是有争议的。在晚期 CKD 的情况下，更密集的血压降低被认为与急性肾损伤、高钾血症和 ESKD 的风险有关。我们旨在进行一项强化血压控制的试点试验，以确定通过使用家庭测量的 BP 滴定血压药物是否可以安全地为 CKD 患者实现较低的 SBP 目标。研究设计 非盲随机对照试验。设置和参与者 108名患有晚期CKD（eGFR ≤30 mL/min/1.73 m2）和高血压的患者。干预 参与者被随机分配到 <120 mmHg 的目标家庭 SBP 目标 （N=66） 或强度较低的 SBP 目标 （N=42）。在研究的前 4 个月滴定抗高血压药物以达到目标家庭 SBP 范围，并维持至研究结束。家庭血压是使用支持无线蓝牙的监视器测量的，该监视器将读数实时传输给提供者。结果 主要疗效结局是两个研究组在 4-12 个月达到的临床 SBP 的差异。安全性结局包括高钾血症、跌倒或晕厥的复合结局，以及开始需要透析或肾移植。结果 强化 SBP 组第 12 个月的平均临床 SBP 为 124.7 mmHg，而低强度 SBP 组为 138.2 mmHg。平均第 4-12 个月，强化 SBP 组达到的平均临床 SBP 比强度较低的 SBP 组达到的平均临床 SBP 低 11.7 mmHg（95% CI 7.5 至 16 mmHg，p<0.001）。两组之间的主要安全性结局差异无统计学意义 （均 p>0.05）。 局限性 样本量小，这可能会限制我们检测不良结局发生率临床显着差异的能力;单中心设计。结论 在实时家庭血压监测的帮助下，<120 mmHg 的临床 SBP 目标是可行的，并且在该研究人群中似乎是安全的晚期 CKD。有必要进行更大规模的试验，以确定晚期 CKD 的最佳血压目标以及与更强化的血压控制相关的风险和益处。