title: Renal denervation in treatment-resistant essential hypertension. A randomized, SHAM-controlled, double-blinded 24-h blood pressure-based trial.
abstract: Renal denervation (RDN), treating resistant hypertension, has, in open trial design, been shown to lower blood pressure (BP) dramatically, but this was primarily with respect to office BP.
  
  
  
  We conducted a SHAM-controlled, double-blind, randomized, single-center trial to establish efficacy data based on 24-h ambulatory BP measurements (ABPM). Inclusion criteria were daytime systolic ABPM at least 145 mmHg following 1 month of stable medication and 2 weeks of compliance registration. All RDN procedures were carried out by an experienced operator using the unipolar Medtronic Flex catheter (Medtronic, Santa Rosa, California, USA).
  
  
  
  We randomized 69 patients with treatment-resistant hypertension to RDN (n = 36) or SHAM (n = 33). Groups were well balanced at baseline. Mean baseline daytime systolic ABPM was 159 ± 12 mmHg (RDN) and 159 ± 14 mmHg (SHAM). Groups had similar reductions in daytime systolic ABPM compared with baseline at 3 months [-6.2 ± 18.8 mmHg (RDN) vs. -6.0 ± 13.5 mmHg (SHAM)] and at 6 months [-6.1 ± 18.9 mmHg (RDN) vs. -4.3 ± 15.1 mmHg (SHAM)]. Mean usage of antihypertensive medication (daily defined doses) at 3 months was equal [6.8 ± 2.7 (RDN) vs. 7.0 ± 2.5 (SHAM)].RDN performed at a single center and by a high-volume operator reduced ABPM to the same level as SHAM treatment and thus confirms the result of the HTN3 trial.
  
  
  
  Further, clinical use of RDN for treatment of resistant hypertension should await positive results from double-blinded, SHAM-controlled trials with multipolar ablation catheters or novel denervation techniques.
authors.affiliation: aDepartment of Cardiology, Aarhus University Hospital, Skejby bUniversity Clinic in Nephrology and Hypertension, Holstebro Hospital, Hospital Jutland West, Holstebro cDepartment of Nephrology, Aarhus University Hospital, Skejby dDepartment of Cardiology, Viborg Hospital, Viborg eDepartment of Cardiology, Randers Hospital, Randers fDepartment of Endocrinology, Aarhus University Hospital, NBG, Skejby gDepartment of Internal Medicine, Silkeborg Hospital, Silkeborg hDepartment of Radiology, Aarhus University Hospital, Skejby, Denmark.
authors.forename: Ole N
authors.initials: ON
authors.lastname: Mathiassen
authors.forename: Henrik
authors.initials: H
authors.lastname: Vase
authors.forename: Jesper N
authors.initials: JN
authors.lastname: Bech
authors.forename: Kent L
authors.initials: KL
authors.lastname: Christensen
authors.forename: Niels H
authors.initials: NH
authors.lastname: Buus
authors.forename: Anne P
authors.initials: AP
authors.lastname: Schroeder
authors.forename: Ole
authors.initials: O
authors.lastname: Lederballe
authors.forename: Hans
authors.initials: H
authors.lastname: Rickers
authors.forename: Ulla
authors.initials: U
authors.lastname: Kampmann
authors.forename: Per L
authors.initials: PL
authors.lastname: Poulsen
authors.forename: Klavs W
authors.initials: KW
authors.lastname: Hansen
authors.forename: Hans E
authors.initials: HE
authors.lastname: Btker
authors.forename: Christian D
authors.initials: CD
authors.lastname: Peters
authors.forename: Morten
authors.initials: M
authors.lastname: Engholm
authors.forename: Jannik B
authors.initials: JB
authors.lastname: Bertelsen
authors.forename: Jens F
authors.initials: JF
authors.lastname: Lassen
authors.forename: Sten
authors.initials: S
authors.lastname: Langfeldt
authors.forename: Gratien
authors.initials: G
authors.lastname: Andersen
authors.forename: Erling B
authors.initials: EB
authors.lastname: Pedersen
authors.forename: Anne
authors.initials: A
authors.lastname: Kaltoft
mesh_terms: D000368:Aged; D000959:Antihypertensive Agents / Q000627:therapeutic use; D001794:Blood Pressure; D018660:Blood Pressure Monitoring, Ambulatory; D017115:Catheter Ablation / Q000379:methods; D003329:Coronary Vasospasm / Q000188:drug therapy / Q000601:surgery*; D004311:Double-Blind Method; D000075222:Essential Hypertension; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy / Q000601:surgery*; D007668:Kidney / Q000294:innervation*; D008297:Male; D008875:Middle Aged; D013562:Sympathectomy / Q000379:methods
chemical_list: D000959:Antihypertensive Agents