AIMS: The SYMPLICITY @entity29073 randomized, blinded, sham-controlled trial confirmed the safety of renal denervation (RDN), but did not meet its primary efficacy endpoint. Prior RDN studies have demonstrated significant and durable reductions in blood pressure. This analysis investigated factors that may help explain these disparate results. METHODS AND RESULTS: @entity1 with resistant @entity101 were randomized 2 : 1 to RDN (n = 364) or sham (n = 171). The primary endpoint was the difference in office systolic blood pressure (SBP) change at 6 months. A multivariable analysis identified predictors of SBP change. Additional analyses examined the influence of medication changes, results in selected subgroups and procedural factors. Between randomization and the 6-month endpoint, 39% of @entity1 underwent medication changes. @entity551 at 6 months were baseline office SBP >= 180 mmHg, @entity1369 antagonist use, and non-use of vasodilators; number of ablations was a predictor in the RDN group. Non-African-American @entity1 receiving RDN had a significantly greater change in office SBP than those receiving sham; -15.2    23.5 vs. -8.6    24.8 mmHg, respectively (P = 0.012). Greater reductions in office and ambulatory SBP, and heart rate were observed with a higher number of ablations and energy delivery in a four-quadrant pattern. CONCLUSIONS: Post hoc analyses, although derived from limited @entity1 cohorts, reveal several potential confounding factors that may partially explain the unexpected blood pressure responses in both the sham control and RDN groups. These hypothesis-generating data further inform the design of subsequent research to evaluate the potential role of RDN in the treatment of resistant @entity101 . CLINICALTRIALSGOV IDENTIFIER: NCT01418261.

Predictors of blood pressure response in the SYMPLICITY XXXX trial.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient'] @entity1369 :: ('MESH:D000450', 'Chemical') :: ['aldosterone'] @entity101 :: ('MESH:D006973', 'Disease') :: ['hypertension'] @entity551 :: ('MESH:D007022', 'Disease') :: ['Predictors of office SBP reduction'] @entity29073 :: ('3347', 'Gene') :: ['HTN-3']
@entity29073 :: (3347,Gene) :: ['HTN-3']
