Böhm M, et al. SPYRAL HTN-OFF MED Pivotal, 2020 (13) |
Untreated patients over the 3–4 weeks before randomization. Clinic BP 150–179/≥90 mmHg and average 24-h ambulatory BP 140–16 mmHg. Mean age: 53 years. (N = 331; 80 patients from randomized Pilot trial and 251 patients from randomized pivotal trial) |
RF-RDN (N = 166) |
SHAM: Renal angiography (N = 165) |
Radiofrequency technique (Multielectrode Symplicity SpiralTM ®) |
Primary end point: change in mean 24-h systolic blood pressure Secondary end point: change in office SBP; changes in morning and nighttime BP Adverse events |
3 |
44 centers in Australia, Austria, Canada, Germany, Greece, Ireland, UK, and USA |
Kandzari DE, et al. SPYRAL HTN-ON MED, 2023 (14) |
Patients with 1–3 drugs from ≥6 weeks, uncontrolled (clinic BP 150–180/≥90 mmHg, 24-h BP 140–170 mmHg). Mean age: 53-55 years. (N = 337; 80 patients from randomized Pilot trial and 257 patients from randomized Expansion trial). |
RF-RDN (N = 206) |
SHAM: Renal angiography (N = 131) |
Radiofrequency technique (Multielectrode Symplicity SpiralTM ®) |
Primary end point: change in ambulatory blood pressure Secondary end point: office BP; changes in morning (daytime) and night-time BP Adverse Events |
6 |
56 clinical centers worldwide (USA, Germany, Japan, UK, Australia, Austria, and Greece) |
Weber MA, et al. REDUCE HTN: REINFORCE, 2020 (15) |
Patients with office SBP of 150 to 180 mmHg and average 24-h ambulatory SBP of 135 to 170 mmHg after medication washout. Mean age: 58 years |
RF-RDN (N = 34) 8 weeks: no antihypertensive medications (unless rescue) 8 weeks to 6 months: add medication if office SBP ≥140 mmHg |
SHAM: Renal Angiography (N = 17) 8 weeks: no antihypertensive medications (unless rescue) 8 weeks to 6 months: add medication if office SBP ≥140 mmHg |
Radiofrequency technique (Vessix Renal Denervation® system transmits radiofrequency energy via bipolar electrodes). |
Primary end point: Mean reduction in average 24-h ambulatory BP. Secondary end point: Daytime ambulatory Office BP Adverse events |
8 weeks 6 months: 12 months |
12 centers in USA |