Renal Denervation in Hypertension

The DENER-HTN study is a, multicenter, prospective, open, randomized, controlled study of the efficacy and cost-effectiveness of renal denervation plus standardized optimal antihypertensive treatment compared to standardized optimal antihypertensive treatment alone in patients with proven resistant hypertension. Patients with essential resistant hypertension will first enter a 4-week run-in period during which they will receive a standardized triple combination therapy (diuretic+ ACE inhibitor+ CCB at maximal dose). After 4 weeks of standardized triple therapy patients will be randomized to renal denervation + optimal antihypertensive treatment compared to standardized optimal antihypertensive treatment if daytime ambulatory BP remains ≥ 135 and/or 85 mmHg. Bilateral renal denervation will be performed using the Symplicity Catheter (Medtronic ®) - a percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery. Study amendment: Extended follow-up of 48 months for all randomized patients.

Inclusion criteria

• Individual is more than 18 and less than 75 years old at time of randomization
• Essential hypertension diagnosed during a complete work-up within the past 2 years
• Office blood pressure ≥140 and/or 90 mmHg despite a stable medication regimen including full tolerated doses of 3 or more anti-hypertensive medications of different classes, including a diuretic
• 2 functional kidneys sizing ≥ 90 mm; eGFR ≥ 40 mL/min/1.73m² (MDRD formula)
• Suitable renal anatomy compatible with the endovascular denervation procedure
• Signed Informed consent
• Confirmed resistant hypertension defined by diurnal ambulatory blood pressure measurement ≥ 135 and/or 85 mmHg after 4 week standardized triple antihypertensive treatment

Exclusion criteria

• Patients with an estimated glomerular filtration rate (eGFR) of less than 40 mL/min/1.73 m2
• Patients with secondary hypertension
• Kaliemia ≥ 6mmol/L
• Patient with single functioning kidney
• Patient with contrast media allergy
• Patient with any implantable device incompatible with radiofrequency energy delivery
• Patient with contra-indication to the anti-hypertensive standardized medication regimen
• Patient with transient or fixed cerebral ischemia within 3 months before inclusion
• Patient with myocardial infarction, unstable angina pectoris, coronary bypass or percutaneous angioplasty within 3 months before inclusion
• Patient with type 1 diabetes mellitus
• Patient with malignancy within the 5 past years
• Patient with atrial fibrillation and/or a brachial circumference of ≥ 42cm