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交感神经肾去神经支配的影响:肾移植术后患者的一项随机研究(ISAR - 去神经支配研究)

Impact of sympathetic renal denervation: a randomized study in patients after renal transplantation (ISAR-denerve).

作者信息

Schneider Simon, Promny Dominik, Sinnecker Daniel, Byrne Robert A, Müller Alexander, Dommasch Michael, Wildenauer Agnes, Schmidt Georg, Heemann Uwe, Laugwitz Karl Ludwig, Baumann Marcus

机构信息

I. Medizinische Klinik und Poliklinik, Department of Cardiology, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.

Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.

出版信息

Nephrol Dial Transplant. 2015 Nov;30(11):1928-36. doi: 10.1093/ndt/gfv311. Epub 2015 Sep 1.

DOI:10.1093/ndt/gfv311
PMID:26333545
Abstract

BACKGROUND

Sympathetic overactivity is frequently observed following renal transplantation (RTx), and post-transplant hypertension is a major contributing factor to graft failure and cardiovascular morbidity. This process is perpetuated by preservation of sympathetic afferent activity from the native non-functional kidneys, in the absence of efferent feedback to the renal transplant, which would otherwise modulate neurohumoral activity. We investigated the feasibility and efficacy of renal sympathetic denervation (RDN) in renal transplant recipients.

METHODS

Patients (n = 18) with post-transplant hypertension were randomized 1:1 to receive RDN or medical treatment alone. The primary efficacy end point was change in office systolic blood pressure (SBP) and mean 24-h ambulatory blood pressure monitoring (ABPM) at 6 months. Safety end points were changes in renal function or renovascular complications.

RESULTS

After 6 months, patients in the RDN group had a significant reduction in office SBP of 23.3 ± 14.5 mmHg (P = 0.001 for change difference between the groups). In ABPM, nocturnal blood pressure was reduced in the RDN group by -10.38 ± 12.8 mmHg (P = 0.06), whereas no change was measured during the day. In the RDN group, significantly more patients converted from non-dippers to dippers (P = 0.035). There were no adverse safety events in either group.

CONCLUSION

RDN is feasible and safe in renal transplant recipients. However, larger sham-controlled studies will be necessary to clarify the potential role of RDN in this population.

CLINICAL TRIAL REGISTRATION

NCT01899456.

摘要

背景

肾移植(RTx)后常观察到交感神经过度活跃,移植后高血压是导致移植肾失功和心血管疾病的主要因素。在缺乏对移植肾的传出反馈(否则可调节神经体液活动)的情况下,来自无功能的原肾的交感传入活动得以保留,使得这一过程持续存在。我们研究了肾交感神经去神经术(RDN)在肾移植受者中的可行性和疗效。

方法

将18例移植后高血压患者按1:1随机分组,分别接受RDN或单纯药物治疗。主要疗效终点是6个月时诊室收缩压(SBP)的变化以及24小时动态血压监测(ABPM)的平均值。安全性终点是肾功能或肾血管并发症的变化。

结果

6个月后,RDN组患者的诊室SBP显著降低23.3±14.5 mmHg(两组变化差异P = 0.001)。在ABPM中,RDN组夜间血压降低了-10.38±12.8 mmHg(P = 0.06),而白天未测得变化。在RDN组,从非勺型血压转变为勺型血压的患者明显更多(P = 0.035)。两组均未发生不良安全事件。

结论

RDN在肾移植受者中是可行且安全的。然而,需要更大规模的假手术对照研究来阐明RDN在该人群中的潜在作用。

临床试验注册

NCT01899456。

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