In light of Medtronic’s announcement of Thursday, 9th January 2014, about SYMPLICITY HTN-3, the Resistant Hypertension Course Scientific Board shares its point of view.
Medtronic, Inc. announced yesterday that its U.S. trial in renal denervation for treatment-resistant hypertension, SYMPLICITY HTN-3, has met its primary safety endpoint, while it did not reach its primary efficacy endpoint, defined as a difference of, at least, 15 mmHg office systolic blood pressure, between sham and active renal denervation groups.
The RHC Board shares its point of view:
The RHC Board chooses to wait until the peer-reviewed publication of clinical data, most likely around end of March 2014, to have further information rather than speculating. We are committing to the careful analysis, with open mind, of this upcoming paper for further comments and sharing with the RHC community the potential reasons why the primary efficacy endpoint is not met.
Although SYMPLICITY HTN-3 included a control group with sham ablation, at the moment, questions remained unanswered since many other published studies have shown that renal denervation significantly reduces office and ambulatory blood pressures.
As a scientific group, we urge investigators to pursue their clinical endeavours, aiming to provide critical information about the role of renal denervation in the treatment of uncontrolled hypertension. Additionally, a great opportunity presents itself to further investigate the role of renal denervation in hypertension and other disease states characterised by an increased sympathetic activity.
The RHC course philosophy focuses on addressing the holistic treatment of an individual patient with difficult to control hypertension and its related challenges, from diagnosis to therapy.
More than ever, the upcoming RHC 2014 meeting, in Berlin, timely provides us with a unique occasion to learn more and exchange on this challenging pathology.
|RHC Course Chairman||RHC Course Chairman|
on behalf of the RHC Board