Abstract
SYMPLICITY HTN-3 results to be announced: a mystery or a story foretold?
Highlights
The SYMPLICITY HTN-1[1] and HTN-2 studies[2] showed that renal denervation (RDN) is feasible as a novel treatment for resistant hypertension
There is little uncertainty about what SYMPLICITY HTN-3 will report at the end of March, based on the published sample size calculations for the primary efficacy endpoint based on office systolic blood pressure[4]
These calculations state that ‘‘assuming a true difference between treatment means of 15 mmHg with a 25 mmHg standard deviation of systolic blood pressure change per group, a sample size of 316 treated and 158 control patients provides over 95% statistical power to demonstrate a difference of more than 5 mmHg between treatment groups with a 1-sided a-level of 0.025’’
Summary
The SYMPLICITY HTN-1[1] and HTN-2 studies[2] showed that renal denervation (RDN) is feasible as a novel treatment for resistant hypertension. There is little uncertainty about what SYMPLICITY HTN-3 will report at the end of March, based on the published sample size calculations for the primary efficacy endpoint based on office systolic blood pressure[4]. These calculations state that ‘‘assuming a true difference between treatment means of 15 mmHg with a 25 mmHg standard deviation of systolic blood pressure change per group, a sample size of 316 treated and 158 control patients provides over 95% statistical power to demonstrate a difference of more than 5 mmHg between treatment groups with a 1-sided a-level of 0.025’’.
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