Single-center, single group study of the efficacy and safety of transcatheter renal denervation for treatment of patients with essential hypertension uncontrolled despite combined pharmacotherapy including 3 or more hypotensive drugs one of which is a diuretic. Bilateral transcatheter renal denervation will be performed on the top of existed pharmacotherapy. Change in blood pressure (BP), left ventricle (LV) mass, carotid artery thickness, renal artery blood flow and renal function, will be assessed at 6 and 12 months of follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
53
Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways
Institute of Cardiology, Siberian Branch of Russian Academy of Medical Sciences
Tomsk, Russia
Change in Office Systolic BP
Time frame: from baseline to 12 months
Number of Serious Adverse Events
A number of first occurrences (within the study period) of any of the following: death, end-stage renal disease, an embolic event resulting in end-organ damage, major bleeding event, renal artery thrombosis, new renal artery stenosis, other serious cardiovascular complications if their relation to the study treatment is assessed at least as possible.
Time frame: from baseline to 12 months
Change in Office Diastolic BP
Time frame: from baseline to 12 months
Change in Mean 24-h Systolic BP
Time frame: from baseline to 12 months
Change in Mean 24-h Diastolic BP
Time frame: from baseline to 12 months
Change in Office Systolic BP
Time frame: from baseline to 6 month
Change in Office Diastolic BP
Time frame: from baseline to 6 month
Change in Mean 24-h Systolic BP
Time frame: from baseline to 6 months
Change in Mean 24-h Diastolic BP
Time frame: from baseline to 6 months
Change in Echocardiographic Left Ventricular Mass
Time frame: from baseline to 6 months
Change in Echocardiographic Left Ventricular Mass
Time frame: from baseline to 12 months
Change in Mean Daytime Systolic BP
Time frame: from baseline to 6 months
Change in Mean Daytime Diastolic BP
Time frame: from baseline to 6 months
Change in Mean Daytime Systolic BP
Time frame: from baseline to 12 months
Change in Mean Daytime Diastolic BP
Time frame: from baseline to 12 months
Change in Mean Nighttime Systolic BP
Time frame: from baseline to 6 months
Change in Mean Nighttime Diastolic BP
Time frame: from baseline to 6 months
Change in Mean Nighttime Systolic BP
Time frame: from baseline to 12 months
Change in Mean Nighttime Diastolic BP
Time frame: from baseline to 12 months
Change in Mean Nighttime Systolic BP Dipping
Mean nighttime BP dipping is a relative difference: absolute difference between mean daytime and mean nighttime BP values divided by mean daytime BP value
Time frame: from baseline to 6 months
Change in Mean Nighttime Diastolic BP Dipping
Mean nighttime BP dipping is a relative difference: absolute difference between mean daytime and mean nighttime BP values divided by mean daytime BP value
Time frame: from baseline to 6 months
Change in Mean Nighttime Systolic BP Dipping
Mean nighttime BP dipping is a relative difference: absolute difference between mean daytime and mean nighttime BP values divided by mean daytime BP value
Time frame: from baseline to 12 months
Change in Mean Nighttime Diastolic BP Dipping
Mean nighttime BP dipping is a relative difference: absolute difference between mean daytime and mean nighttime BP values divided by mean daytime BP value
Time frame: from baseline to 12 months
Change in Daytime Systolic BP Variability
daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring (ABPM)
Time frame: from baseline to 12 months
Change in Daytime Diastolic BP Variability
daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring
Time frame: from baseline to 12 months
Change in Nighttime Systolic BP Variability
daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring
Time frame: from baseline to 12 months
Change in Nighttime Diastolic BP Variability
daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring
Time frame: from baseline to 12 months
Change in Daytime Systolic BP Variability
daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring
Time frame: from baseline to 6 months
Change in Daytime Diastolic BP Variability
daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring
Time frame: from baseline to 6 months
Change in Nighttime Systolic BP Variability
daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring
Time frame: from baseline to 6 months
Change in Nighttime Diastolic BP Variability
daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring
Time frame: from baseline to 6 months
Change in Serum Creatinine
Time frame: from baseline to 1 week
Change in Serum Creatinine
Time frame: from baseline to 6 months
Change in Serum Creatinine
Time frame: from baseline to 12 months
Change in Casual Proteinuria
Change of protein concentration in morning urine sample
Time frame: from baseline to 1 week
Change in Casual Proteinuria
Change of protein concentration in morning urine sample
Time frame: from baseline to 6 months
Change in Casual Proteinuria
Change of protein concentration in morning urine sample
Time frame: from baseline to 12 months
Change in Specific Gravity of Urine
Change of specific gravity of morning urine sample
Time frame: from baseline to 1 week
Change in Specific Gravity of Urine
Change of specific gravity of morning urine sample
Time frame: from baseline to 6 months
Change in Specific Gravity of Urine
Change of specific gravity of morning urine sample
Time frame: from baseline to 12 months
Change in Renal Resistive Index Measured by Doppler Flowmetry in Left Main Renal Artery
Resistive index calculated as relative difference between assessed by ultrasound Doppler maximal and minimal blood flow velocities, i.e. absolute difference between maximal and minimal blood flow velocities divided by maximal flow velocity
Time frame: from baseline to 6 months
Change in Renal Resistive Index Measured by Doppler Flowmetry in Right Main Renal Artery
Resistive index calculated as relative difference between assessed by ultrasound Doppler maximal and minimal blood flow velocities, i.e. absolute difference between maximal and minimal blood flow velocities divided by maximal flow velocity
Time frame: from baseline to 6 months
Change in Resistive Index Measured by Renal Doppler Flowmetry in Left Main Renal Artery
Resistive index calculated as relative difference between assessed by ultrasound Doppler maximal and minimal blood flow velocities, i.e. absolute difference between maximal and minimal blood flow velocities divided by maximal flow velocity
Time frame: from baseline to 12 months
Change in Resistive Index Measured by Renal Doppler Flowmetry in Right Main Renal Artery
Resistive index calculated as relative difference between assessed by ultrasound Doppler maximal and minimal blood flow velocities, i.e. absolute difference between maximal and minimal blood flow velocities divided by maximal flow velocity
Time frame: from baseline to 12 months
Change in Ultrasound Intima Media Thickness of Carotid Artery
Time frame: from baseline to 6 months
Change in Ultrasound Intima Media Thickness of Carotid Artery
Time frame: from baseline to 12 months
Change in Arterial Stiffness
Change of cardio-ankle vascular index(CAVI) assessed by vascular screening device VaSera VS1000 (name of the model)
Time frame: from baseline to 12 months
Change in Arterial Stiffness
Change of cardio-ankle vascular index(CAVI) assessed by vascular screening device VaSera VS1000
Time frame: from baseline to 6 months
Change in Morning Surge of BP
Time frame: from baseline to 12 months
Change in Morning Surge of BP
Time frame: from baseline to 6 months
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