Table 2.
Different clinical trials on renal denervation
| Trial | Mean followup | Reduction in SBP/DBP | Location | Type | Primary outcome | Safety data |
| SIMPLICITY I 2009, (n = 50)[35] | 6 mo | 22/11 | Australia/Europe | Catheter-based | Substantial and sustained BP reduction w/o serious adverse events | One case of Renal artery dissection |
| 12 mo | 27/17 | Substantial and sustained BP reduction w/o serious adverse events | ||||
| SIMPLICITY I F/u study 2011[42] (n = 153) | 24 mo | 32/14 | Australia/Europe/United States | Catheter-based | Substantial BP reduction | Groin pseudoaneurysms |
| SIMPLICITY II 2010, (n = 106)[43] | 6 mo | 32/12 | Australia/Europe/United States | Catheter-based | Meaningful reduction in BP | Hypertensive emergency in 3 cases |
| Mahfoud 2013, (n = 245)[48] | 3 mo | 19/13 | ||||
| (n = 236) | 6 mo | 17/12 | ||||
| (n = 90) | 12 mo | 16/10 | Australia/Germany | Catheter-based | RDN imporved BP relevantly in office and ambulatory scenarios | No adverse events reported |
| Witowski et al[49] | 6 mo | 34/13 | Poland/United States | Catheter-based | Improvement in severity of sleep apnea, glucose tolerance and BP | No adverse events reported |
| Brandt et al[75] 2012 (n = 110) | 6 mo | 29/8 | Austria/Germany | Catheter-based | Improves BP, arterial stiffness and central hemodynamics | No adverse events reported |
| Davies et al[76] 2012, (n = 7) | 6 mo | 7/0.6 | United Kingdom/United States | Catheter-based | Improvement in symptoms and exercise capacity | No adverse events reported |
| Esler et al[62] 2012 (n = 106) | 24 mo | 32/12 | Australia/Europe/United States | Catheter-based | Saftety and continues benefit with denervation | Hypotension after denervation |
| Hering et al[64] 2012 (n = 15) | 6 mo | 32/15 | Australia/Europe/United States | Catheter-based | Safe and BP beneficial in resistant HTN and CKD stage 3-4 | No peri- or postprocedural complications reported |
| 12 mo | 33/19 | Safe and BP beneficial in resistant HTN and CKD stage 3-4 | ||||
| Mahfoud et al[77], 2011 | 3 mo | 28/10 | Germany | Catheter-based | Reduction in BP and glycemic control | None reported |
| Lambert et al[78] 2012, (n = 40) | 3 mo | 16/6 | Australia/Europe | Catheter-based | Quality of life improved after denervation but not directly associated to BP reduction | None reported |
| Mahfound et al[77] 2011, (n = 37) | 1 mo | 28/10 | ||||
| 3 mo | 32/12 | Australia/Germany | Catheter-based | Improvement in glucose levels and insulin sensitivity in addition to BP reduction | No significant adverse events reported | |
| Ott et al[63] 2013, (n = 19) | 6 mo | 16/7 | Germany/United States | Catheter-based | Significantly improvement in peripheral and central BP | No changes in renal function and perfusion |
| Schlaich et al[61] 2013, (n = 9) | 3 mo | 18/4 | Germany/Australia/Poland/United States | Catheter-based | RDN causes sustained lower BP in ESRD | One patient developed femoral pseudo-aneurysm |
| (n = 8) | 6 mo | 16/6 | ||||
| (n = 6) | 12 mo | 28/5 | ||||
| Steinberg et al[51] 2013, (n = 13) | 12 mo | 25/10 | United States | Catheter-based | RDN patients displayed a significant reduction in systolic and diastolic pressure and maintained | No Adverse events reported |
| Ukena et al[50] 2012, (n = 2) | 6 mo | No Info | Germany/ United States | Catheter-based | Ventricular tachyarrhythmias significantly improved after RDN | No complications reported |
| Vaclavik et al[79] 2013, (n = 1) | 3 mo | No effect in this unilateral procedure | Czech Republic | Catheter-based | Unilateral Renal sympathetic denervation does not lower BP | No complications reported |
CKD: Chronic kidney disease.