title: Randomized sham-controlled trial of renal sympathetic denervation in mild resistant hypertension.
abstract: Few data are available with regard to the effectiveness of renal sympathetic denervation in patients with resistant hypertension yet only mildly elevated blood pressure (BP). Patients with resistant hypertension and slightly elevated BP (day-time systolic pressure, 135-149 and diastolic pressure, 90-94 mm Hg on 24-hour ambulatory measurement) were randomized in a 1:1 ratio to renal sympathetic denervation with the Symplicity Flex Catheter (Medtronic) or an invasive sham procedure. The primary efficacy end point was the change in 24-hour systolic BP at 6 months between groups in the intention to treat population. A total of 71 patients underwent randomization. Baseline day-time systolic BP was 144.4±4.8 mm Hg in patients assigned to denervation and 143.0±4.7 mm Hg in patients randomized to the sham procedure. The mean change in 24-hour systolic BP in the intention to treat cohort at 6 months was -7.0 mm Hg (95% confidence interval, -10.8 to -3.2) for patients undergoing denervation and -3.5 mm Hg (95% confidence interval, -6.7 to -0.2) in the sham group (P=0.15). In the per protocol population, the change in 24-hour systolic BP at 6 months was -8.3 mm Hg (95% confidence interval, -11.7 to -5.0) for patients undergoing denervation and -3.5 mm Hg (95% confidence interval, -6.8 to -0.2) in the sham group (P=0.042). In patients with mild resistant hypertension, renal sympathetic denervation failed to show a significant reduction in the primary end point of 24-hour systolic BP at 6 months between groups in the intention to treat analysis.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT01656096.
authors.affiliation: From the Medical Clinic II-Department of Cardiology, Angiology and Intensive Care Medicine, University Heart Center Lübeck, University of Lübeck, Lübeck, Germany (S.D., I.E., H.T.); and Department of Internal Medicine/Cardiology, Heart Center, University of Leipzig, Leipzig, Germany (S.D., T.O., D.H., K.K., K.R., M.S., M.P., U.M., G.S., I.E., H.T., P.L.). stdesch@web.de.
authors.forename: Steffen
authors.initials: S
authors.lastname: Desch
authors.affiliation: From the Medical Clinic II-Department of Cardiology, Angiology and Intensive Care Medicine, University Heart Center Lübeck, University of Lübeck, Lübeck, Germany (S.D., I.E., H.T.); and Department of Internal Medicine/Cardiology, Heart Center, University of Leipzig, Leipzig, Germany (S.D., T.O., D.H., K.K., K.R., M.S., M.P., U.M., G.S., I.E., H.T., P.L.).
authors.forename: Thomas
authors.initials: T
authors.lastname: Okon
authors.affiliation: From the Medical Clinic II-Department of Cardiology, Angiology and Intensive Care Medicine, University Heart Center Lübeck, University of Lübeck, Lübeck, Germany (S.D., I.E., H.T.); and Department of Internal Medicine/Cardiology, Heart Center, University of Leipzig, Leipzig, Germany (S.D., T.O., D.H., K.K., K.R., M.S., M.P., U.M., G.S., I.E., H.T., P.L.).
authors.forename: Diana
authors.initials: D
authors.lastname: Heinemann
authors.affiliation: From the Medical Clinic II-Department of Cardiology, Angiology and Intensive Care Medicine, University Heart Center Lübeck, University of Lübeck, Lübeck, Germany (S.D., I.E., H.T.); and Department of Internal Medicine/Cardiology, Heart Center, University of Leipzig, Leipzig, Germany (S.D., T.O., D.H., K.K., K.R., M.S., M.P., U.M., G.S., I.E., H.T., P.L.).
authors.forename: Konrad
authors.initials: K
authors.lastname: Kulle
authors.affiliation: From the Medical Clinic II-Department of Cardiology, Angiology and Intensive Care Medicine, University Heart Center Lübeck, University of Lübeck, Lübeck, Germany (S.D., I.E., H.T.); and Department of Internal Medicine/Cardiology, Heart Center, University of Leipzig, Leipzig, Germany (S.D., T.O., D.H., K.K., K.R., M.S., M.P., U.M., G.S., I.E., H.T., P.L.).
authors.forename: Karoline
authors.initials: K
authors.lastname: Röhnert
authors.affiliation: From the Medical Clinic II-Department of Cardiology, Angiology and Intensive Care Medicine, University Heart Center Lübeck, University of Lübeck, Lübeck, Germany (S.D., I.E., H.T.); and Department of Internal Medicine/Cardiology, Heart Center, University of Leipzig, Leipzig, Germany (S.D., T.O., D.H., K.K., K.R., M.S., M.P., U.M., G.S., I.E., H.T., P.L.).
authors.forename: Melanie
authors.initials: M
authors.lastname: Sonnabend
authors.affiliation: From the Medical Clinic II-Department of Cardiology, Angiology and Intensive Care Medicine, University Heart Center Lübeck, University of Lübeck, Lübeck, Germany (S.D., I.E., H.T.); and Department of Internal Medicine/Cardiology, Heart Center, University of Leipzig, Leipzig, Germany (S.D., T.O., D.H., K.K., K.R., M.S., M.P., U.M., G.S., I.E., H.T., P.L.).
authors.forename: Martin
authors.initials: M
authors.lastname: Petzold
authors.affiliation: From the Medical Clinic II-Department of Cardiology, Angiology and Intensive Care Medicine, University Heart Center Lübeck, University of Lübeck, Lübeck, Germany (S.D., I.E., H.T.); and Department of Internal Medicine/Cardiology, Heart Center, University of Leipzig, Leipzig, Germany (S.D., T.O., D.H., K.K., K.R., M.S., M.P., U.M., G.S., I.E., H.T., P.L.).
authors.forename: Ulrike
authors.initials: U
authors.lastname: Müller
authors.affiliation: From the Medical Clinic II-Department of Cardiology, Angiology and Intensive Care Medicine, University Heart Center Lübeck, University of Lübeck, Lübeck, Germany (S.D., I.E., H.T.); and Department of Internal Medicine/Cardiology, Heart Center, University of Leipzig, Leipzig, Germany (S.D., T.O., D.H., K.K., K.R., M.S., M.P., U.M., G.S., I.E., H.T., P.L.).
authors.forename: Gerhard
authors.initials: G
authors.lastname: Schuler
authors.affiliation: From the Medical Clinic II-Department of Cardiology, Angiology and Intensive Care Medicine, University Heart Center Lübeck, University of Lübeck, Lübeck, Germany (S.D., I.E., H.T.); and Department of Internal Medicine/Cardiology, Heart Center, University of Leipzig, Leipzig, Germany (S.D., T.O., D.H., K.K., K.R., M.S., M.P., U.M., G.S., I.E., H.T., P.L.).
authors.forename: Ingo
authors.initials: I
authors.lastname: Eitel
authors.affiliation: From the Medical Clinic II-Department of Cardiology, Angiology and Intensive Care Medicine, University Heart Center Lübeck, University of Lübeck, Lübeck, Germany (S.D., I.E., H.T.); and Department of Internal Medicine/Cardiology, Heart Center, University of Leipzig, Leipzig, Germany (S.D., T.O., D.H., K.K., K.R., M.S., M.P., U.M., G.S., I.E., H.T., P.L.).
authors.forename: Holger
authors.initials: H
authors.lastname: Thiele
authors.affiliation: From the Medical Clinic II-Department of Cardiology, Angiology and Intensive Care Medicine, University Heart Center Lübeck, University of Lübeck, Lübeck, Germany (S.D., I.E., H.T.); and Department of Internal Medicine/Cardiology, Heart Center, University of Leipzig, Leipzig, Germany (S.D., T.O., D.H., K.K., K.R., M.S., M.P., U.M., G.S., I.E., H.T., P.L.).
authors.forename: Philipp
authors.initials: P
authors.lastname: Lurz
mesh_terms: D000368:Aged; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use; D001795:Blood Pressure Determination; D016001:Confidence Intervals; D004351:Drug Resistance; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006973:Hypertension / Q000175:diagnosis* / Q000188:drug therapy / Q000601:surgery*; D007668:Kidney / Q000294:innervation* / Q000601:surgery; D008297:Male; D008875:Middle Aged; D012016:Reference Values; D018570:Risk Assessment; D012720:Severity of Illness Index; D016037:Single-Blind Method; D013562:Sympathectomy / Q000379:methods*; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents
keywords: blood pressure; blood pressure monitoring, ambulatory; randomized controlled trial