The DENER-HTN study is a, multicenter, prospective, open, randomized, controlled study of the effectiveness and costs of renal denervation in addition to standardized medical treatment compared to medical treatment alone in subjects with resistant hypertension. Bilateral renal denervation will be performed using the Symplicity Catheter - a percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
121
Patients are treated with the renal denervation plus a standardized optimal antihypertensive treatment which is adapted every month starting two month after randomization on the basis of home BP monitoring results at follow-up visits.
Patients are treated with a standardized optimal antihypertensive treatment which is adapted every month starting two month after randomization on the basis of home BP monitoring results at follow-up visits.
CIC Hopital europeen george pompidou
Paris, France
Mean diurnal systolic blood pressure assessed by ABPM
Time frame: Baseline to 6 months
Cost-effectiveness evaluation
Time frame: 1 year
Antihypertensive medication score
Time frame: baseline to 15 months
Adverse events of renal denervation
Time frame: baseline to 48 months
Detailed analysis of blood pressure
Time frame: baseline to 15 months
Change in average 24-hour and nighttime Systolic Blood Pressure by ambulatory blood pressure monitoring
Time frame: baseline to 15 months
Change in average 24-hour, daytime and nighttime diastolic Blood Pressure, pulse pressure and heart rate by ambulatory blood pressure monitoring
Time frame: baseline to 15 months
Change in Systolic/diastolic Blood Pressure by home blood pressure monitoring
Time frame: baseline to 15 months
Change in office Systolic/diastolic Blood Pressure
Time frame: baseline to 15 months
Adherence to antihypertensive Medication
Time frame: baseline to 15 months
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