The DENERHTN Randomized Controlled Trial: Renal Denervation for Resistant Hypertension Revisited

Despite large reductions in blood pressure seen in early studies of renal denervation, the SYMPLICITY HTN-3 randomized trial failed to show a reduction in systolic blood pressure with renal denervation when compared to medical therapy alone. As a result, interest in renal denervation as a treatment for resistant hypertension has waned.  In the DENERHTN trial, Azizi and colleagues assessed the incremental benefit of adding renal denervation to standardized stepped-care antihypertensive treatment (SSAHT) for patients with resistant hypertension in an open-label, randomized-controlled trial with blinded endpoint evaluation. After four weeks of a standardized anti-hypertensive regimen to confirm resistant hypertension, patients were randomized to renal denervation in addition to SSAHT versus SSAHT alone. The primary endpoint was the mean change in daytime systolic blood pressure after six months as assessed by ambulatory monitoring. Of the 106 patients randomized (53 in each group), 101 had endpoints available for final analysis (48 in the intervention group and 53 in the control group). At six months, patients receiving renal denervation had a significant difference in mean change in daytime ambulatory systolic blood pressure when compared to the control group with a baseline-adjusted difference of −5.9 mm Hg (−11.3 to −0.5; p=0.03). These differences were obtained with a similar number of anti-hypertensives and drug-adherence in both groups as well as an acceptable safety profile for the intervention (three minor adverse events with renal denervation and a comparable decrease in estimated glomerular filtration rate in both groups).

Conclusions

When added to a stepped antihypertensive treatment strategy, renal denervation led to a greater decrease in ambulatory blood pressure for patients with resistant hypertension than medications alone. These findings may reinvigorate interest in renal denervation and point to the need for additional trials to fully inform the role of this procedure in hypertension care.

 

Summarized by Jehu S. Mathew and Steven M. Bradley


  • Azizi M, Sapoval M, Gosse P, Monge M, Bobrie G, Delsart P, Midulla M, Mounier-Vehier C, Courand PY, Lantelme P, Denolle T, Dourmap-Collas C, Trillaud H, Pereira H, Plouin PF, Chatellier G, the Renal Denervation for Hypertension i. Optimum and stepped care standardised antihypertensive treatment with or without renal denervation for resistant hypertension (denerhtn): A multicentre, open-label, randomised controlled trial. Lancet. 2015 Jan 23. pii: S0140-6736(14)61942-5. [Epub ahead of print]