Why the study?
Does renal nerve denervation reduce blood pressure in patients with resistant hypertension?
Does renal nerve denervation reduce blood pressure in patients with resistant hypertension?
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Highlights the critical need to account for medication adherence when interpreting the results of renal denervation trials for resistant hypertension.
ince publication of the SYMPLICITY HTN-3 trial (Renal Denervation in Patients With Uncontrolled Hypertension) results in 2014, which reported a similar blood pressure (BP) reduction in subjects with resistant hypertension who had either renal nerve denervation (RND) or sham intervention, there has been much discussion as to whether RND truly provides antihypertensive benefit. There has also been concern that changes in medication adherence by patients participating in RND trials, in particular, immediately after having the procedure done or not, might be confounding the observed results. To explain the BP reductions in both the truly treated and sham-treated groups that occurred in SYMPLICITY HTN-3, one would have to suppose that the procedure had little effect and both patient groups were suddenly, but equally more adherent after randomization, such that the similar BP reductions were simply attributable to patients actually taking their medications; or, alternatively, that the procedure did have a true antihypertensive effect that was, however, obscured by increased medication adherence in the sham-treated patients. Because SYMPLICITY HTN-3 did not include biochemical assessment of medication adherence, such consideration has had to remain speculative.
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David A. Calhoun (2016) studied this question.
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