title: A controlled trial of renal denervation for resistant hypertension.
abstract: BACKGROUND
  Prior unblinded studies have suggested that catheter-based renal-artery denervation reduces blood pressure in patients with resistant hypertension.
  
  
  METHODS
  We designed a prospective, single-blind, randomized, sham-controlled trial. Patients with severe resistant hypertension were randomly assigned in a 2:1 ratio to undergo renal denervation or a sham procedure. Before randomization, patients were receiving a stable antihypertensive regimen involving maximally tolerated doses of at least three drugs, including a diuretic. The primary efficacy end point was the change in office systolic blood pressure at 6 months; a secondary efficacy end point was the change in mean 24-hour ambulatory systolic blood pressure. The primary safety end point was a composite of death, end-stage renal disease, embolic events resulting in end-organ damage, renovascular complications, or hypertensive crisis at 1 month or new renal-artery stenosis of more than 70% at 6 months.
  
  
  RESULTS
  A total of 535 patients underwent randomization. The mean (±SD) change in systolic blood pressure at 6 months was -14.13±23.93 mm Hg in the denervation group as compared with -11.74±25.94 mm Hg in the sham-procedure group (P<0.001 for both comparisons of the change from baseline), for a difference of -2.39 mm Hg (95% confidence interval [CI], -6.89 to 2.12; P=0.26 for superiority with a margin of 5 mm Hg). The change in 24-hour ambulatory systolic blood pressure was -6.75±15.11 mm Hg in the denervation group and -4.79±17.25 mm Hg in the sham-procedure group, for a difference of -1.96 mm Hg (95% CI, -4.97 to 1.06; P=0.98 for superiority with a margin of 2 mm Hg). There were no significant differences in safety between the two groups.
  
  
  CONCLUSIONS
  This blinded trial did not show a significant reduction of systolic blood pressure in patients with resistant hypertension 6 months after renal-artery denervation as compared with a sham control. (Funded by Medtronic; SYMPLICITY HTN-3 ClinicalTrials.gov number, NCT01418261.).
authors.affiliation: From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School (D.L.B., L.M.), Boston University School of Public Health (R.D.), and Harvard Clinical Research Institute (R.D., L.M.) - all in Boston; Piedmont Heart Institute, Atlanta (D.E.K.); the Division of Cardiology, Henry Ford Hospital (W.W.O.), and Wayne State University and the Detroit Medical Center (J.M.F.) - all in Detroit; Baptist Cardiac and Vascular Institute, Miami (B.T.K.); New York Presbyterian Hospital, Columbia University Medical Center, and Cardiovascular Research Foundation, New York (M.B.L.); Medtronic CardioVascular, Santa Rosa, CA (M.L., M.N., S.A.C.); University of Alabama at Birmingham, Birmingham (S.O.); Prairie Heart Institute, Springfield, IL (K.R.-S.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (S.A.C., R.R.T.); and University of Chicago Medicine, Chicago (G.L.B.).
authors.forename: Deepak L
authors.initials: DL
authors.lastname: Bhatt
authors.forename: David E
authors.initials: DE
authors.lastname: Kandzari
authors.forename: William W
authors.initials: WW
authors.lastname: O'Neill
authors.forename: Ralph
authors.initials: R
authors.lastname: D'Agostino
authors.forename: John M
authors.initials: JM
authors.lastname: Flack
authors.forename: Barry T
authors.initials: BT
authors.lastname: Katzen
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
authors.forename: Minglei
authors.initials: M
authors.lastname: Liu
authors.forename: Laura
authors.initials: L
authors.lastname: Mauri
authors.forename: Manuela
authors.initials: M
authors.lastname: Negoita
authors.forename: Sidney A
authors.initials: SA
authors.lastname: Cohen
authors.forename: Suzanne
authors.initials: S
authors.lastname: Oparil
authors.forename: Krishna
authors.initials: K
authors.lastname: Rocha-Singh
authors.forename: Raymond R
authors.initials: RR
authors.lastname: Townsend
authors.forename: George L
authors.initials: GL
authors.lastname: Bakris
mesh_terms: D000368:Aged; D001794:Blood Pressure; D003714:Denervation; D005260:Female; D006801:Humans; D006973:Hypertension / Q000601:surgery*; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011859:Radiography; D012077:Renal Artery / Q000000981:diagnostic imaging / Q000294:innervation / Q000601:surgery*; D016037:Single-Blind Method; D017211:Treatment Failure
chemical_list: D010919:Placebos