Although sound physiological principles and surgical precedent underpin renal denervation as a therapy for treatment resistant hypertension, and early clinical studies had produced encouraging results, the first sham-controlled study (SYMPLICITY HTN-3) failed to achieve its primary efficacy endpoint.
Although the first results from studies suggested important benefits regarding blood pressure (BP) control in resistant hypertension by the use of diverse systems of renal denervation (RDN) in the setting of resistant hypertension, the Symplicity HTN-3, randomized sham-controlled trial reduced the enthusiasm and led to a more critical approach towards this neuromodulation innovative therapy.
We compared ambulatory BP dynamics in Japanese and American black and white populations with treatment-resistant hypertension.Methods and Results:Both HTN-Japan (n=41) and SYMPLICITY HTN-3 (n=384 white and n=140 black patients) enrolled patients with office SBP ≥160 mmHg and 24-h ambulatory SBP ≥135 mmHg while on ≥3 antihypertensive medications.
The SYMPLICITY HTN-3 trial, which randomized subjects to renal denervation (RDN) or sham control, was designed to evaluate the efficacy and safety of RDN for the treatment of resistant hypertension.Outcomes were previously reported.
The effectiveness of renal sympathetic denervation (RDN) as a treatment for therapy-resistant hypertension has been doubted as the Simplicity-HTN-3 trial was unable to show any treatment benefit over sham procedure.
However, the recently published Symplicity HTN-3 study, the largest and most rigorously designed sham-controlled clinical trial, while confirming the safety of the procedure, failed to demonstrate a BP lowering effect beyond that of a sham procedure in patients with resistant hypertension.
Despite promising results in initial trials, renal denervation failed to achieve its efficacy end points as a treatment for resistant hypertension in the SYMPLICITY HTN-3 trial, the largest trial of this treatment to date (N Engl J Med 2014; 370:1393-1401).