• Hypertension · Apr 2015

    Randomized Controlled Trial Multicenter Study

    First report of the Global SYMPLICITY Registry on the effect of renal artery denervation in patients with uncontrolled hypertension.

    • Michael Böhm, Felix Mahfoud, Christian Ukena, Uta C Hoppe, Krzysztof Narkiewicz, Manuela Negoita, Luis Ruilope, Markus P Schlaich, Roland E Schmieder, Robert Whitbourn, Bryan Williams, Uwe Zeymer, Andreas Zirlik, Giuseppe Mancia, and GSR Investigators.
    • From the Kardiologie, Angiologie und Internistische Intensivmedizin, Universitätskliniken des Saarlandes, Klinik für Innere Medizin III, Homburg/Saar, Germany (M.B., F.M, C.U.); Department of Internal Medicine II, Paracelsus University Salzburg, Salzburg, Austria (U.C.H.);Department of Hypertension and Diabetology, Medical University of Gdansk, Gdansk, Poland (K.N.); Global Clinical Research, Coronary and Structural Heart Disease Management, Medtronic Inc, Santa Rosa, CA (M.N.); Institute of Research & Hypertension Unit, Department of Nephrology, Hospital 12 de Octubre, Madrid, Spain (L.R.); School of Medicine and Pharmacology-Royal Perth Hospital Unit, The University of Western Australia, Perth, Australia (M.P.S.); Department of Nephrology and Hypertension, University Hospital Erlangen, Erlangen, Germany (R.E.S.); Cardiovascular Research Centre, Interventional Cardiology, St. Vincent's Hospital, Melbourne, Australia (R.W.); Institute of Cardiovascular Sciences, University College London (UCL), National Institute for Health Research UCL Hospitals Biomedical Research Centre, London, United Kingdom (B.W.); Klinikum der Stadt Ludwigshafen am Rhein, Ludwigshafen am Rhein, Germany (U.Z.); Department of Cardiology and Angiology I, Universitäts-Herzzentrum Freiburg, Bad Krozingen, Freiburg, Germany (A.Z.); and IRCCS Istituto Auxologico Italiano, Center of Epidemiology and Clinical Trials, University of Milano-Bicocca, Milan, Italy (G.M.). michael.boehm@uks.eu.
    • Hypertension. 2015 Apr 1;65(4):766-74.

    UnlabelledThis study aimed to assess the safety and effectiveness of renal denervation using the Symplicity system in real-world patients with uncontrolled hypertension (NCT01534299). The Global SYMPLICITY Registry is a prospective, open-label, multicenter registry. Office and 24-hour ambulatory blood pressures (BPs) were measured. Change from baseline to 6 months was analyzed for all patients and for subgroups based on baseline office systolic BP, diabetic status, and renal function; a cohort with severe hypertension (office systolic pressure, ≥160 mm Hg; 24-hour systolic pressure, ≥135 mm Hg; and ≥3 antihypertensive medication classes) was also included. The analysis included protocol-defined safety events. Six-month outcomes for 998 patients, including 323 in the severe hypertension cohort, are reported. Mean baseline office systolic BP was 163.5±24.0 mm Hg for all patients and 179.3±16.5 mm Hg for the severe cohort; the corresponding baseline 24-hour mean systolic BPs were 151.5±17.0 and 159.0±15.6 mm Hg. At 6 months, the changes in office and 24-hour systolic BPs were -11.6±25.3 and -6.6±18.0 mm Hg for all patients (P<0.001 for both) and -20.3±22.8 and -8.9±16.9 mm Hg for those with severe hypertension (P<0.001 for both). Renal denervation was associated with low rates of adverse events. After the procedure through 6 months, there was 1 new renal artery stenosis >70% and 5 cases of hospitalization for a hypertensive emergency. In clinical practice, renal denervation resulted in significant reductions in office and 24-hour BPs with a favorable safety profile. Greater BP-lowering effects occurred in patients with higher baseline pressures.Clinical Trial RegistrationURL: www.clinicaltrials.gov. Unique identifier: NCT01534299.© 2015 American Heart Association, Inc.

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