Michel Azizi1, Helena Pereira2, Idir Hamdidouche2, Philippe Gosse2, Matthieu Monge2, Guillaume Bobrie2, Pascal Delsart2, Claire Mounier-Véhier2, Pierre-Yves Courand2, Pierre Lantelme2, Thierry Denolle2, Caroline Dourmap-Collas2, Xavier Girerd2, Jean Michel Halimi2, Faiez Zannad2, Olivier Ormezzano2, Bernard Vaïsse2, Daniel Herpin2, Jean Ribstein2, Bernard Chamontin2, Jean-Jacques Mourad2, Emile Ferrari2, Pierre-François Plouin2, Vincent Jullien2, Marc Sapoval2, Gilles Chatellier2. 1. From Paris-Descartes University, France (M.A., P.-F.P., V.J., M.S., G.C.); Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Hypertension Unit, France (M.A., G.B., P.-F.P.); INSERM, CIC1418, Paris, France (M.A., H.P., G.C.); Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Clinical Research Unit, France (H.P., G.C.); Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Department of Pharmacology, France (I.H., V.J.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint André, Cardiology/Hypertension Department, France (P.G.); Institut Mutualiste Montsouris, Paris, France (M.M.); Centre Hospitalier Régional Universitaire de Lille, Hôpital Cardiologique, Médecine Vasculaire et HTA, France (P.D., C.M.-V.); Hôpital Croix-Rousse, Cardiology Department, European Society of Hypertension Excellence Centre, Hospices Civils de Lyon, and Université de Lyon, CREATIS UMR5220; INSERM U1044; INSA-Lyon; Université Claude Bernard Lyon 1; Hospices Civils de Lyon, France (P.-Y.C., P.L.); Hôpital Arthur Gardiner, Centre d'excellence en HTA Rennes-Dinard, France (T.D.); Centre Hospitalier Universitaire de Rennes, Service de Cardiologie et Maladies Vasculaires, France (C.D.-C.); Assistance Publique-Hôpitaux de Paris, Hôpital de la Pitié Salpétrière, France (X.G.); Hôpital Bretonneau, Tours, France (J.M.H.); CHU Nancy-Brabois, Nancy, France (F.Z.); CHU de Grenoble, France (O.O.); CHU de la Timone, Marseille, France (B.V.); CHU de Poitiers, Cardiologie, France (D.H.); CHRU Montpellier, France (J.R.); CHU Rangueil, Toulouse, France (B.C.); Hôpital Avicenne, Bobigny, France (J.-J.M.); Hôpital Pasteur, Nice, France (E.F.); INSERM, UMR 1129, Paris, France (V.J.); Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Vascular and Oncological Interventional Radiology Department, France (M.S.). michel.azizi@aphp.fr. 2. From Paris-Descartes University, France (M.A., P.-F.P., V.J., M.S., G.C.); Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Hypertension Unit, France (M.A., G.B., P.-F.P.); INSERM, CIC1418, Paris, France (M.A., H.P., G.C.); Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Clinical Research Unit, France (H.P., G.C.); Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Department of Pharmacology, France (I.H., V.J.); Centre Hospitalier Universitaire de Bordeaux, Hôpital Saint André, Cardiology/Hypertension Department, France (P.G.); Institut Mutualiste Montsouris, Paris, France (M.M.); Centre Hospitalier Régional Universitaire de Lille, Hôpital Cardiologique, Médecine Vasculaire et HTA, France (P.D., C.M.-V.); Hôpital Croix-Rousse, Cardiology Department, European Society of Hypertension Excellence Centre, Hospices Civils de Lyon, and Université de Lyon, CREATIS UMR5220; INSERM U1044; INSA-Lyon; Université Claude Bernard Lyon 1; Hospices Civils de Lyon, France (P.-Y.C., P.L.); Hôpital Arthur Gardiner, Centre d'excellence en HTA Rennes-Dinard, France (T.D.); Centre Hospitalier Universitaire de Rennes, Service de Cardiologie et Maladies Vasculaires, France (C.D.-C.); Assistance Publique-Hôpitaux de Paris, Hôpital de la Pitié Salpétrière, France (X.G.); Hôpital Bretonneau, Tours, France (J.M.H.); CHU Nancy-Brabois, Nancy, France (F.Z.); CHU de Grenoble, France (O.O.); CHU de la Timone, Marseille, France (B.V.); CHU de Poitiers, Cardiologie, France (D.H.); CHRU Montpellier, France (J.R.); CHU Rangueil, Toulouse, France (B.C.); Hôpital Avicenne, Bobigny, France (J.-J.M.); Hôpital Pasteur, Nice, France (E.F.); INSERM, UMR 1129, Paris, France (V.J.); Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Vascular and Oncological Interventional Radiology Department, France (M.S.).
Abstract
BACKGROUND: The DENERHTN trial (Renal Denervation for Hypertension) confirmed the blood pressure-lowering efficacy of renal denervation added to a standardized stepped-care antihypertensive treatment for resistant hypertension at 6 months. We report the influence of adherence to antihypertensive treatment on blood pressure control. METHODS:One hundred six patients with hypertension resistant to 4 weeks of treatment withindapamide 1.5 mg/d, ramipril 10 mg/d (or irbesartan 300 mg/d), and amlodipine 10 mg/d were randomly assigned to renal denervation plus standardized stepped-care antihypertensive treatment, or the same antihypertensive treatment alone. For standardized stepped-care antihypertensive treatment, spironolactone 25 mg/d, bisoprolol 10 mg/d, prazosin 5 mg/d, and rilmenidine 1 mg/d were sequentially added at monthly visits if home blood pressure was ≥135/85 mm Hg after randomization. We assessed adherence to antihypertensive treatment at 6 months by drug screening in urine/plasma samples from 85 patients. RESULTS: The numbers of fully adherent (20/40 versus 21/45), partially nonadherent (13/40 versus 20/45), or completely nonadherent patients (7/40 versus 4/45) to antihypertensive treatment were not different in the renal denervation and the control groups, respectively (P=0.3605). The difference in the change in daytime ambulatory systolic blood pressure from baseline to 6 months between the 2 groups was -6.7 mm Hg (P=0.0461) in fully adherent and -7.8 mm Hg (P=0.0996) in nonadherent (partially nonadherent plus completely nonadherent) patients. The between-patient variability of daytime ambulatory systolic blood pressure was greater for nonadherent than for fully adherent patients. CONCLUSIONS: In the DENERHTN trial, the prevalence of nonadherence to antihypertensive drugs at 6 months was high (≈50%) but not different in the renal denervation and control groups. Regardless of adherence to treatment, renal denervation plus standardized stepped-care antihypertensive treatment resulted in a greater decrease in blood pressure than standardized stepped-care antihypertensive treatment alone. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01570777.
RCT Entities:
BACKGROUND: The DENERHTN trial (Renal Denervation for Hypertension) confirmed the blood pressure-lowering efficacy of renal denervation added to a standardized stepped-care antihypertensive treatment for resistant hypertension at 6 months. We report the influence of adherence to antihypertensive treatment on blood pressure control. METHODS: One hundred six patients with hypertension resistant to 4 weeks of treatment with indapamide 1.5 mg/d, ramipril 10 mg/d (or irbesartan 300 mg/d), and amlodipine 10 mg/d were randomly assigned to renal denervation plus standardized stepped-care antihypertensive treatment, or the same antihypertensive treatment alone. For standardized stepped-care antihypertensive treatment, spironolactone 25 mg/d, bisoprolol 10 mg/d, prazosin 5 mg/d, and rilmenidine 1 mg/d were sequentially added at monthly visits if home blood pressure was ≥135/85 mm Hg after randomization. We assessed adherence to antihypertensive treatment at 6 months by drug screening in urine/plasma samples from 85 patients. RESULTS: The numbers of fully adherent (20/40 versus 21/45), partially nonadherent (13/40 versus 20/45), or completely nonadherent patients (7/40 versus 4/45) to antihypertensive treatment were not different in the renal denervation and the control groups, respectively (P=0.3605). The difference in the change in daytime ambulatory systolic blood pressure from baseline to 6 months between the 2 groups was -6.7 mm Hg (P=0.0461) in fully adherent and -7.8 mm Hg (P=0.0996) in nonadherent (partially nonadherent plus completely nonadherent) patients. The between-patient variability of daytime ambulatory systolic blood pressure was greater for nonadherent than for fully adherent patients. CONCLUSIONS: In the DENERHTN trial, the prevalence of nonadherence to antihypertensive drugs at 6 months was high (≈50%) but not different in the renal denervation and control groups. Regardless of adherence to treatment, renal denervation plus standardized stepped-care antihypertensive treatment resulted in a greater decrease in blood pressure than standardized stepped-care antihypertensive treatment alone. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01570777.
Authors: Simone Romano; Chiara Idolazzi; Cristiano Fava; Luigi Fondrieschi; Mario Celebrano; Pietro Delva; Lorella Branz; Angela Donato; Andrea Dalbeni; Pietro Minuz Journal: High Blood Press Cardiovasc Prev Date: 2018-06-29
Authors: Candace D McNaughton; Nancy J Brown; Russell L Rothman; Dandan Liu; Edmond K Kabagambe; Phillip D Levy; Wesley H Self; Alan B Storrow; Sean P Collins; Christianne L Roumie Journal: Hypertension Date: 2017-06-26 Impact factor: 10.190