Impact of sympathetic renal denervation: a randomized study in patients after renal transplantation (ISAR-denerve).
Schneider S, Promny D, et al.Nephrol Dial Transplant 2015 Nov; 30(11): 1928-36
Aims
To investigate the feasibility and efficacy of renal sympathitic denervation (RDN) in renal transplant recipients with poorly controlled post-transplant hypertension.
Interventions
Patients were randomized to RDN of the native kidneys in addition to medical treatment versus medical treatment alone.
Participants
18 renal transplant recipients aged 18–85 years ≥ 6 months after transplantation with a diagnosis of persistent hypertension.
Outcomes
Primary outcomes were the change in office systolic blood pressure (SBP), mean 24-h ambulatory SBP, renal function, creatinine and albuminuria, and renovascular complications. Secondary outcomes included effects on sympathetic activity, 24-h ambulatory BP monitoring (ABPM) and daytime and night-time ambulatory BP.
Follow-up
6 months
CET Conclusions
This is an interesting study of renal denervation in transplant patients with resistant hypertension not controlled by antihypertensive drugs. Eighteen patients were randomised to receive renal sympathetic denervation plus medical treatment or medical treatment alone. It had originally been planned to recruit 20 patients in each arm, but during the recruitment phase SIMPLICITY-HTN-3 study was published in which there was a sham treatment arm showing no benefit of renal denervation and hence recruitment was stopped. In this analysis of the 18 patients that had not been randomised at that stage, there was a reduction in office systolic blood pressure that was significant but no alteration in the ambulatory blood pressure at six months. There were no safety issues with the radiofrequency ablation of the sympathetic nerves showing that it is feasible and safe in renal transplant recipients but the authors conclude that larger sham control studies will be necessary to clarify the potential risk of this procedure in a transplant population. Whether this is really needed after the results of SIMPLICITY trial, I am doubtful.
Data analysis
Available case analysis
Trial registration
Clinicaltrials.gov - NCT01899456