SYMPLICITY HTN-Japan - First Randomized Controlled Trial of Catheter-Based Renal Denervation in Asian Patients -

Circ J. 2015;79(6):1222-9. doi: 10.1253/circj.CJ-15-0150. Epub 2015 Apr 24.

Abstract

Background: SYMPLICITY HTN-Japan is a prospective, randomized, controlled trial comparing renal artery denervation (RDN) with standard pharmacotherapy for treatment of resistant hypertension (systolic blood pressure [SBP] ≥160 mmHg on ≥3 anti-hypertensive drugs including a diuretic for ≥6 weeks). When SYMPLICITY HTN-3 failed to meet the primary efficacy endpoint, the HTN-Japan enrollment was discontinued before completion. METHODS AND RESULTS: The 6-month change in office and 24-h ambulatory SBP were compared between RDN (n=22) and control (n=19) subjects. Mean baseline office SBP was 181.0±18.0 mmHg and 178.7±17.8 mmHg for the RDN and control groups, respectively. The 6-month office SBP change was -16.6±18.5 mmHg for RDN subjects (P<0.001) and -7.9±21.0 mmHg for control subjects (P=0.117); the difference between the 6-month change in RDN and control subjects was -8.64 (95% CI: -21.12 to 3.84, P=0.169). Mean 24-h SBP was 164.7±18.3 (RDN group) and 163.3±17.2 mmHg (control group). The 24-h 6-month SBP change for the RDN group was -7.52±11.98 mmHg (P=0.008) and -1.38±10.2 mmHg (P=0.563) for control subjects; the between-group difference in SBP change was -6.15 (95% CI: -13.23 to 0.94, P=0.087). No major adverse events were reported.

Conclusions: SYMPLICITY HTN-Japan, the first randomized controlled trial of RDN in an Asian population, was underpowered for the primary endpoint analysis and did not demonstrate a significant difference in 6-month BP change between RDN and control subjects.

Trial registration: ClinicalTrials.gov NCT01644604.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Antihypertensive Agents / therapeutic use
  • Asian Continental Ancestry Group*
  • Blood Pressure Monitoring, Ambulatory
  • Catheter Ablation*
  • Combined Modality Therapy
  • Comorbidity
  • Female
  • Humans
  • Hypertension / drug therapy
  • Hypertension / surgery*
  • Japan
  • Male
  • Middle Aged
  • Mineralocorticoid Receptor Antagonists / therapeutic use
  • Prospective Studies
  • Renal Artery / innervation*
  • Research Design
  • Sample Size
  • Sympathectomy / methods*
  • Treatment Outcome

Substances

  • Antihypertensive Agents
  • Mineralocorticoid Receptor Antagonists

Associated data

  • ClinicalTrials.gov/NCT01644604