Randomized Sham-Controlled Trial of Renal Sympathetic Denervation in Mild Resistant Hypertension

Steffen Desch*, Thomas Okon, Diana Heinemann, Konrad Kulle, Karoline Röhnert, Melanie Sonnabend, Martin Petzold, Ulrike Müller, Gerhard Schuler, Ingo Eitel, Holger Thiele, Philipp Lurz

*Corresponding author for this work
161 Citations (Scopus)

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.

Original languageEnglish
JournalHypertension
Volume65
Issue number6
Pages (from-to)1202-1208
Number of pages7
ISSN0194-911X
DOIs
Publication statusPublished - 20.06.2015

Research Areas and Centers

  • Centers: Cardiological Center Luebeck (UHZL)

DFG Research Classification Scheme

  • 205-12 Cardiology, Angiology

Cite this