title: Impact of renal denervation on 24-hour ambulatory blood pressure: results from SYMPLICITY HTN-3.
abstract: BACKGROUND
  Prior studies of catheter-based renal artery denervation have not systematically performed ambulatory blood pressure monitoring (ABPM) to assess the efficacy of the procedure.
  
  
  OBJECTIVE
  SYMPLICITY HTN-3 (Renal Denervation in Patients With Uncontrolled Hypertension) was a prospective, blinded, randomized, sham-controlled trial. The current analysis details the effect of renal denervation or a sham procedure on ABPM measurements 6 months post-randomization.
  
  
  METHODS
  Patients with resistant hypertension were randomized 2:1 to renal denervation or sham control. Patients were on a stable antihypertensive regimen including maximally tolerated doses of at least 3 drugs including a diuretic before randomization. The powered secondary efficacy endpoint was a change in mean 24-h ambulatory systolic blood pressure (SBP). Nondipper to dipper (nighttime blood pressure [BP] 10% to 20% lower than daytime BP) conversion was calculated at 6 months.
  
  
  RESULTS
  The 24-h ambulatory SBP changed -6.8 ± 15.1 mm Hg in the denervation group and -4.8 ± 17.3 mm Hg in the sham group: difference of -2.0 mm Hg (95% confidence interval [CI]: -5.0 to 1.1; p = 0.98 with a 2 mm Hg superiority margin). The daytime ambulatory SBP change difference between groups was -1.1 (95% CI: -4.3 to 2.2; p = 0.52). The nocturnal ambulatory SBP change difference between groups was -3.3 (95 CI: -6.7 to 0.1; p = 0.06). The percent of nondippers converted to dippers was 21.2% in the denervation group and 15.0% in the sham group (95% CI: -3.8% to 16.2%; p = 0.30). Change in 24-h heart rate was -1.4 ± 7.4 in the denervation group and -1.3 ± 7.3 in the sham group; (95% CI: -1.5 to 1.4; p = 0.94).
  
  
  CONCLUSIONS
  This trial did not demonstrate a benefit of renal artery denervation on reduction in ambulatory BP in either the 24-h or day and night periods compared with sham (Renal Denervation in Patients With Uncontrolled Hypertension [SYMPLICITY HTN-3]; NCT01418261).
authors.affiliation: ASH Comprehensive Hypertension Center, University of Chicago Medicine, Chicago, Illinois. Electronic address: gbakris@medicine.bsd.uchicago.edu.
authors.forename: George L
authors.initials: GL
authors.lastname: Bakris
authors.affiliation: School of Medicine, Renal Electrolyte Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Raymond R
authors.initials: RR
authors.lastname: Townsend
authors.affiliation: Medtronic CardioVascular, Santa Rosa, California.
authors.forename: Minglei
authors.initials: M
authors.lastname: Liu
authors.affiliation: School of Medicine, Renal Electrolyte Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Medtronic CardioVascular, Santa Rosa, California.
authors.forename: Sidney A
authors.initials: SA
authors.lastname: Cohen
authors.affiliation: Department of Medicine, Division of Cardiology, Harvard Clinical Research Institute and Boston University School of Public Health, Boston, Massachusetts.
authors.forename: Ralph
authors.initials: R
authors.lastname: D'Agostino
authors.affiliation: Department of Medicine, Wayne State University and Detroit Medical Center, Detroit, Michigan.
authors.forename: John M
authors.initials: JM
authors.lastname: Flack
authors.affiliation: Department of Medicine, Division of Cardiology, Piedmont Heart Institute, Atlanta, Georgia.
authors.forename: David E
authors.initials: DE
authors.lastname: Kandzari
authors.affiliation: Department of Medicine, Division of Cardiology, Baptist Cardiac and Vascular Institute, Miami, Florida.
authors.forename: Barry T
authors.initials: BT
authors.lastname: Katzen
authors.affiliation: Department of Medicine, Division of Cardiology, New York Presbyterian Hospital, Columbia University Medical Center, and Cardiovascular Research Foundation, New York, New York.
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
authors.affiliation: Department of Medicine, Division of Cardiology, Harvard Clinical Research Institute, Brigham and Women's Hospital Heart and Vascular Center, and Harvard Medical School, Boston, Massachusetts.
authors.forename: Laura
authors.initials: L
authors.lastname: Mauri
authors.affiliation: Medtronic CardioVascular, Santa Rosa, California.
authors.forename: Manuela
authors.initials: M
authors.lastname: Negoita
authors.affiliation: Department of Medicine, Division of Cardiology, Henry Ford Hospital, Detroit, Michigan.
authors.forename: William W
authors.initials: WW
authors.lastname: O'Neill
authors.affiliation: Department of Medicine, Division of Cardiology, University of Alabama at Birmingham, Birmingham, Alabama.
authors.forename: Suzanne
authors.initials: S
authors.lastname: Oparil
authors.affiliation: Department of Medicine, Division of Cardiology, Prairie Heart Institute, Springfield, Illinois.
authors.forename: Krishna
authors.initials: K
authors.lastname: Rocha-Singh
authors.affiliation: Department of Medicine, Division of Cardiology, Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, Massachusetts.
authors.forename: Deepak L
authors.initials: DL
authors.lastname: Bhatt
mesh_terms: D001794:Blood Pressure; D018660:Blood Pressure Monitoring, Ambulatory; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006973:Hypertension / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012077:Renal Artery / Q000294:innervation* / Q000601:surgery*; D013562:Sympathectomy; D013997:Time Factors
keywords: ambulatory blood pressure monitoring; renal denervation; resistant hypertension