Efficacy and Safety of Radiofrequency Renal Denervation in Drug Resistant Hypertension

Not Applicable

Completed

Conditions: Hypertension

Interventions: Procedure: Bilateral radiofrequency sympathetic renal denervation

Registration Number: NCT01499810

Lead Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 53

Inclusion Criteria

Age ≥ 18 and ≤ 80 years at time of randomization
Informed consent
Treatment with full doses of 3 or more anti-hypertensive medications of different classes, of which one is a diuretic.
Office Systolic BP (SBP) ≥ 160 mmHg or Diastolic BP (DBP) ≥ 100 mmHg

Exclusion Criteria

An estimated glomerular filtration rate (eGFR) of < 30 mL/min/1.73 m2
Ambulatory Blood Pressure Monitoring (ABPM) 24 hour average SBP < 135 mmHg or DBP < 85 mmHg
Symptomatic(secondary) hypertension
Severe renal artery stenosis or renal arteries abnormalities
Individual is pregnant, nursing or planning to be pregnant
Severe hepatic dysfunction
Any other clinically important renal, hematological, metabolic, neurological, gastrointestinal, hepatic or pulmonary disorders or dysfunctions preventing study participation (investigator's assessment)

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Renal denervation	Bilateral radiofrequency sympathetic renal denervation	All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.

Primary Outcome Measures

Name	Time	Method
Number of Serious Adverse Events	from baseline to 12 months	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.
Change in Office Systolic BP	from baseline to 12 months

Secondary Outcome Measures

Name	Time	Method
Change in Office Diastolic BP	from baseline to 6 month
Change in Mean Daytime Systolic BP	from baseline to 12 months
Change in Nighttime Systolic BP Variability	from baseline to 6 months	daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring
Change in Serum Creatinine	from baseline to 12 months
Change in Office Systolic BP	from baseline to 6 month
Change in Echocardiographic Left Ventricular Mass	from baseline to 12 months
Change in Mean Daytime Diastolic BP	from baseline to 12 months
Change in Mean 24-h Diastolic BP	from baseline to 6 months
Change in Nighttime Diastolic BP Variability	from baseline to 6 months	daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring
Change in Casual Proteinuria	from baseline to 12 months	Change of protein concentration in morning urine sample
Change in Mean Nighttime Systolic BP	from baseline to 12 months
Change in Mean Nighttime Diastolic BP	from baseline to 12 months
Change in Mean 24-h Systolic BP	from baseline to 6 months
Change in Daytime Diastolic BP Variability	from baseline to 6 months	daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring
Change in Mean Nighttime Systolic BP Dipping	from baseline to 12 months	Mean nighttime BP dipping is a relative difference: absolute difference between mean daytime and mean nighttime BP values divided by mean daytime BP value
Change in Mean Nighttime Diastolic BP Dipping	from baseline to 12 months	Mean nighttime BP dipping is a relative difference: absolute difference between mean daytime and mean nighttime BP values divided by mean daytime BP value
Change in Ultrasound Intima Media Thickness of Carotid Artery	from baseline to 12 months
Change in Arterial Stiffness	from baseline to 6 months	Change of cardio-ankle vascular index(CAVI) assessed by vascular screening device VaSera VS1000
Change in Daytime Systolic BP Variability	from baseline to 6 months	daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring
Change in Specific Gravity of Urine	from baseline to 12 months	Change of specific gravity of morning urine sample
Change in Renal Resistive Index Measured by Doppler Flowmetry in Left Main Renal Artery	from baseline to 6 months	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
Change in Resistive Index Measured by Renal Doppler Flowmetry in Left Main Renal Artery	from baseline to 12 months	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
Change in Resistive Index Measured by Renal Doppler Flowmetry in Right Main Renal Artery	from baseline to 12 months	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
Change in Renal Resistive Index Measured by Doppler Flowmetry in Right Main Renal Artery	from baseline to 6 months	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
Change in Morning Surge of BP	from baseline to 6 months