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通过24小时血压监测预测和评估肾去神经支配的影响:DENERHTN研究(肾去神经支配治疗高血压)

Twenty-Four-Hour Blood Pressure Monitoring to Predict and Assess Impact of Renal Denervation: The DENERHTN Study (Renal Denervation for Hypertension).

作者信息

Gosse Philippe, Cremer Antoine, Pereira Helena, Bobrie Guillaume, Chatellier Gilles, Chamontin Bernard, Courand Pierre-Yves, Delsart Pascal, Denolle Thierry, Dourmap Caroline, Ferrari Emile, Girerd Xavier, Michel Halimi Jean, Herpin Daniel, Lantelme Pierre, Monge Matthieu, Mounier-Vehier Claire, Mourad Jean-Jacques, Ormezzano Olivier, Ribstein Jean, Rossignol Patrick, Sapoval Marc, Vaïsse Bernard, Zannad Faiez, Azizi Michel

机构信息

From the Hopital Saint André, University Hospital of Bordeaux, France (P.G., A.C.); Institut National de la Santé et de la Recherche Médicale (INSERM), Centre d'Investigations Cliniques 1418, Paris, France (H.P., G.C., M.A.); Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Hypertension Unit, Paris, France (G.B., M.M., M.A.); Paris-Descartes University, Paris, France (G.C., M.A.); Service de médecine Interne et Hypertension artérielle Pole Cardiovasculaire et métabolique, University Hospital Rangueil, Toulouse, France (B.C.); Cardiology Department, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, F-69004, Lyon, France (P.-Y.C.); Hôpital Cardiologique, Service de médecine vasculaire et HTA, University Hospital Lille, France (P.D., P.L., C.M.-V.); Arthur Gardiner Hospital, Dinard, France (T.D.); University Hospital of Rennes, France (C.D.); Department of Cardiology, University Hospital Nice, France (E.F.); Unité de Prévention Cardio Vasculaire, University Hospital Pitié-Salpêtrière, Paris, France (X.G.); Service de Néphrologie-Immunologie clinique, University hospital Tours et EA4245 Université François-Rabelais, Tours, France (J.M.H.); Department of Cardiology, University Hospital Poitiers, France (D.H.); University Hospital Avicenne-APHP, Bobigny, France (J.-J.M.); Department of Cardiology, University Hospital and INSERM U1039, Bioclinic Radiopharmaceutics Laboratory, Grenoble, France (O.O.); Department of Medicine and Hypertension, University Hospital of Montpellier, France (J.R.); INSERM, Centre d'Investigations Cliniques, Plurithématique 14-33, and INSERM U1116, and University Hospital Nancy and Université de Lorraine and F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), France (P.R., F.Z.); Vascular and Oncological Interventional Radiology Department, Hôpital Européen Georges Pompidou, Paris, France (M.S.); and University Hospital La Timone, Marseille, France (B.V.).

出版信息

Hypertension. 2017 Mar;69(3):494-500. doi: 10.1161/HYPERTENSIONAHA.116.08448. Epub 2017 Jan 23.

DOI:10.1161/HYPERTENSIONAHA.116.08448
PMID:28115517
Abstract

UNLABELLED

The DENERHTN trial (Renal Denervation for Hypertension) confirmed the blood pressure (BP) lowering efficacy of renal denervation added to a standardized stepped-care antihypertensive treatment for resistant hypertension at 6 months. We report here the effect of denervation on 24-hour BP and its variability and look for parameters that predicted the BP response. Patients with resistant hypertension were randomly assigned to denervation plus stepped-care treatment or treatment alone (control). Average and standard deviation of 24-hour, daytime, and nighttime BP and the smoothness index were calculated on recordings performed at randomization and 6 months. Responders were defined as a 6-month 24-hour systolic BP reduction ≥20 mm Hg. Analyses were performed on the per-protocol population. The significantly greater BP reduction in the denervation group was associated with a higher smoothness index (=0.02). Variability of 24-hour, daytime, and nighttime BP did not change significantly from baseline to 6 months in both groups. The number of responders was greater in the denervation (20/44, 44.5%) than in the control group (11/53, 20.8%; =0.01). In the discriminant analysis, baseline average nighttime systolic BP and standard deviation were significant predictors of the systolic BP response in the denervation group only, allowing adequate responder classification of 70% of the patients. Our results show that denervation lowers ambulatory BP homogeneously over 24 hours in patients with resistant hypertension and suggest that nighttime systolic BP and variability are predictors of the BP response to denervation.

CLINICAL TRIAL REGISTRATION

URL: https://www.clinicaltrials.gov. Unique identifier: NCT01570777.

摘要

未标注

DENERHTN试验(肾去神经支配治疗高血压)证实了在标准化阶梯式降压治疗基础上加用肾去神经支配对顽固性高血压患者6个月时的降压疗效。我们在此报告去神经支配对24小时血压及其变异性的影响,并寻找预测血压反应的参数。顽固性高血压患者被随机分为去神经支配加阶梯式治疗组或单纯治疗组(对照组)。在随机分组时和6个月时进行的记录上计算24小时、日间和夜间血压的平均值和标准差以及平滑指数。反应者定义为6个月时24小时收缩压降低≥20 mmHg。对符合方案人群进行分析。去神经支配组显著更大的血压降低与更高的平滑指数(=0.02)相关。两组24小时、日间和夜间血压的变异性从基线到6个月均无显著变化。去神经支配组的反应者数量(20/44,44.5%)多于对照组(11/53,20.8%;P=0.01)。在判别分析中,仅基线平均夜间收缩压和标准差是去神经支配组收缩压反应的显著预测因子,能对70%的患者进行充分的反应者分类。我们的结果表明,去神经支配可使顽固性高血压患者24小时动态血压均匀降低,并提示夜间收缩压及其变异性是去神经支配血压反应的预测因子。

临床试验注册

网址:https://www.clinicaltrials.gov。唯一标识符:NCT01570777。

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