title: Adjusted drug treatment is superior to renal sympathetic denervation in patients with true treatment-resistant hypertension.
abstract: We aimed to investigate for the first time the blood pressure (BP)-lowering effect of renal sympathetic denervation (RDN) versus clinically adjusted drug treatment in true treatment-resistant hypertension (TRH) after excluding patients with confounding poor drug adherence. Patients with apparent TRH (n=65) were referred for RDN, and those with secondary and spurious hypertension (n=26) were excluded. TRH was defined as office systolic BP (SBP) >140 mm Hg, despite maximally tolerated doses of ≥3 antihypertensive drugs including a diuretic. In addition, ambulatory daytime SBP >135 mm Hg after witnessed intake of antihypertensive drugs was required, after which 20 patients had normalized BP and were excluded. Patients with true TRH were randomized and underwent RDN (n=9) performed with Symplicity Catheter System versus clinically adjusted drug treatment (n=10). The study was stopped early for ethical reasons because RDN had uncertain BP-lowering effect. Office SBP and diastolic BP in the drug-adjusted group changed from 160±14/88±13 mm Hg (±SD) at baseline to 132±10/77±8 mm Hg at 6 months (P<0.0005 and P=0.02, SBP and diastolic BP, respectively) and in the RDN group from 156±13/91±15 to 148±7/89±8 mm Hg (P=0.42 and P=0.48, SBP and diastolic BP, respectively). SBP and diastolic BP were significantly lower in the drug-adjusted group at 6 months (P=0.002 and P=0.004, respectively), and absolute changes in SBP were larger in the drug-adjusted group (P=0.008). Ambulatory BPs changed in parallel to office BPs. Our data suggest that adjusted drug treatment has superior BP lowering effects compared with RDN in patients with true TRH. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT01673516.
authors.affiliation: Department of Cardiology, Ullevål Hospital, N-0407 Oslo, Norway. s.e.kjeldsen@medisin.uio.no.
authors.forename: Fadl Elmula M
authors.initials: FE
authors.lastname: Fadl Elmula
authors.forename: Pavel
authors.initials: P
authors.lastname: Hoffmann
authors.forename: Anne C
authors.initials: AC
authors.lastname: Larstorp
authors.forename: Eigil
authors.initials: E
authors.lastname: Fossum
authors.forename: Magne
authors.initials: M
authors.lastname: Brekke
authors.forename: Sverre E
authors.initials: SE
authors.lastname: Kjeldsen
authors.forename: Eyvind
authors.initials: E
authors.lastname: Gjønnæss
authors.forename: Ulla
authors.initials: U
authors.lastname: Hjørnholm
authors.forename: Vibeke N
authors.initials: VN
authors.lastname: Kjaer
authors.forename: Morten
authors.initials: M
authors.lastname: Rostrup
authors.forename: Ingrid
authors.initials: I
authors.lastname: Os
authors.forename: Aud
authors.initials: A
authors.lastname: Stenehjem
authors.forename: Aud
authors.initials: A
authors.lastname: Høieggen
mesh_terms: D000328:Adult; D000368:Aged; D000959:Antihypertensive Agents / Q000494:pharmacology / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects / Q000502:physiology; D018660:Blood Pressure Monitoring, Ambulatory; D004305:Dose-Response Relationship, Drug; D005260:Female; D006339:Heart Rate / Q000187:drug effects / Q000502:physiology; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000503:physiopathology / Q000601:surgery*; D007668:Kidney / Q000294:innervation*; D008297:Male; D008875:Middle Aged; D009819:Office Visits; D011446:Prospective Studies; D013562:Sympathectomy / Q000379:methods*; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents
keywords: blood pressure; drug therapy; hypertension