Symplicity HTN-3 TRIAL
|Format||Single-blinded multi-center randomised sham-controlled trial|
|Treatment||Bilateral renal sympathetic denervation|
|Control||Sham procedure (renal angiography alone)|
|Inclusion criteria||Systolic blood pressure >= 160mmHg averaged over 3 visits
Taking maximally tolerated doses of three or more anti-hypertensive medications of complementary classes, one of which had to be a diuretic at an appropriate dose
|Exclusion criteria||Any changes in antihypertensive medication in the previous 2 weeks
Systolic blood pressure < 135 on final pre-treatment visit
Known secondary causes of hypertension
More than one hospitalization for a hypertensive emergency in the previous year.
Anatomical exclusion criteria:
Renal-artery stenosis of more than 50%
Prior renal-artery intervention
Multiple renal arteries
Renal artery of less than 4 mm in diameter
Treatable segment of less than 20 mm in length.
|Primary endpoint||Mean change in office systolic blood pressure from baseline to 6 months in the denervation group, as compared with the mean change in the sham control group, with a superiority margin of 5 mm Hg|
|Secondary endpoint(s)||Change in mean 24-hour ambulatory systolic blood pressure at 6 months
The primary safety end point was a composite of major adverse events, defined as death from any cause, end- stage renal disease, an embolic event resulting in end-organ damage, renal-artery or other vascular complications, or hypertensive crisis within 30 days or new renal-artery stenosis of more than 70% within 6 months.
|Details||Patients were sedated during the procedure and so were unaware of whether they received renal denervation or the sham procedure.|
|Brief summary:||Renal denervation failed to reduce office or ambulatory pressures when compared to a sham control|