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Twenty-Four-Hour Blood Pressure Monitoring to Predict and Assess Impact of Renal Denervation: The DENERHTN Study
Philippe Gosse1, Antoine Cremer2, Helena Pereira2
1From 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.). philippe.gosse@chu-bordeaux.fr.
Abstract:
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 (P=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%; P=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.
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