Subscribe: Latest / All - Designed by Dr James P Howard (Google+)
Symplicity HTN-3 TRIAL |
|
|---|---|
| Problem | Resistant hypertension |
| Format | Single-blinded multi-center randomised sham-controlled trial |
| Treatment | Bilateral renal sympathetic denervation |
| Control | Sham procedure (renal angiography alone) |
| Population | 535 patients |
| 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% Renal-artery aneurysm 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. |
| Follow-up | 6 months |
| 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 |