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Symplicity HTN-2 TRIAL |
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|---|---|
| Problem | Resistant hypertension |
| Format | Multi-center open-label RCT |
| Treatment | Renal sympathetic denervation |
| Control | No procedure |
| Population | 106 patients |
| Inclusion criteria | Patients aged 18–85 years with a systolic blood pressure of 160 mm Hg or more (≥150 mm Hg in patients with type 2 diabetes), despite compliance with three or more antihypertensive drugs, were eligible for inclusion. |
| Exclusion criteria | Exclusion criteria included an estimated glomerular filtration rate (eGFR; based on the Modification of Diet in Renal Disease criteria12) of less than 45 mL/min per 1·73 m2, type 1 diabetes, contraindications to MRI, substantial stenotic valvular heart disease, pregnancy or planned pregnancy during the study, and a history of myocardial infarction, unstable angina, or cerebrovascular accident in the previous 6 months. |
| Follow-up | 6 months |
| Primary endpoint | Between-group change in average office-based measurements of systolic blood pressure from baseline to 6 months after randomisation. |
| Secondary endpoint(s) | Secondary endpoints were acute procedural safety, chronic procedural safety (reduction of eGFR >25% or new stenosis >60% confirmed by angiogram at 6 months), a composite cardiovascular endpoint (myocardial infarction, sudden cardiac death, new-onset heart failure, death from progressive heart failure, stroke, aortic or lower limb revascularisation procedure, lower limb amputation, death from aortic or peripheral arterial disease, dialysis, death because of renal failure, hospital admission for hypertensive emergency unrelated to non-adherence or non-persistence with drugs, and hospital admission for atrial fibrillation), and additional measurements of blood-pressure reduction at 6 months after randomisation consisting of occurrence of 10 mm Hg or more systolic response, achievement of target systolic blood pressure, change in 24-h ambulatory blood pressure, and change in home-based blood-pressure measurements. |
| Details | . |
| Brief summary: | Renal denervation appeared to lead to 30+mmHg office drops (though less impressive ABPM drops). THIS TRIAL HAS BEEN SUPERSEDED BY THE NEGATIVE TRIAL SYMPLICITY HTN-3. |
| PAPER: Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial. | |
|---|---|
| Date | 17 Nov 2010 |
| Journal | Lancet. 2010 Dec 4;376(9756):1903-9. doi: 10.1016/S0140-6736(10)62039-9. |
| Information | Renal denervation versus no treatment (unblinded) -33mmHg drop in office pressures -14mmHg reduction on ambulatory monitoring |