Efficacy and Safety of Radiofrequency Renal Denervation in Drug Resistant Hypertension

Study of Efficacy and Safety of Radiofrequency Sympathetic Renal Denervation for Treatment of Drug Resistant Hypertension

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 Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Procedure: Bilateral radiofrequency sympathetic renal denervation

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Tomsk, Russian Federation, 634012
    • Institute of Cardiology, Siberian Branch of Russian Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Procedure: Bilateral radiofrequency sympathetic renal denervation; 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; Other Names: Percutaneous radiofrequency ablation of renal nerves; Transcatheter renal denervation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Office Systolic BP		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.	from baseline to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Office Diastolic BP		from baseline to 12 months
Change in Mean 24-h Systolic BP		from baseline to 12 months
Change in Mean 24-h Diastolic BP		from baseline to 12 months
Change in Office Systolic BP		from baseline to 6 month
Change in Office Diastolic BP		from baseline to 6 month
Change in Mean 24-h Systolic BP		from baseline to 6 months
Change in Mean 24-h Diastolic BP		from baseline to 6 months
Change in Echocardiographic Left Ventricular Mass		from baseline to 6 months
Change in Echocardiographic Left Ventricular Mass		from baseline to 12 months
Change in Mean Daytime Systolic BP		from baseline to 6 months
Change in Mean Daytime Diastolic BP		from baseline to 6 months
Change in Mean Daytime Systolic BP		from baseline to 12 months
Change in Mean Daytime Diastolic BP		from baseline to 12 months
Change in Mean Nighttime Systolic BP		from baseline to 6 months
Change in Mean Nighttime Diastolic BP		from baseline to 6 months
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 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	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	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	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	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)	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	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	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	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	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	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	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	from baseline to 6 months
Change in Serum Creatinine		from baseline to 1 week
Change in Serum Creatinine		from baseline to 6 months
Change in Serum Creatinine		from baseline to 12 months
Change in Casual Proteinuria	Change of protein concentration in morning urine sample	from baseline to 1 week
Change in Casual Proteinuria	Change of protein concentration in morning urine sample	from baseline to 6 months
Change in Casual Proteinuria	Change of protein concentration in morning urine sample	from baseline to 12 months
Change in Specific Gravity of Urine	Change of specific gravity of morning urine sample	from baseline to 1 week
Change in Specific Gravity of Urine	Change of specific gravity of morning urine sample	from baseline to 6 months
Change in Specific Gravity of Urine	Change of specific gravity of morning urine sample	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	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	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	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	from baseline to 12 months
Change in Ultrasound Intima Media Thickness of Carotid Artery		from baseline to 6 months
Change in Ultrasound Intima Media Thickness of Carotid Artery		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)	from baseline to 12 months
Change in Arterial Stiffness	Change of cardio-ankle vascular index(CAVI) assessed by vascular screening device VaSera VS1000	from baseline to 6 months
Change in Morning Surge of BP		from baseline to 12 months
Change in Morning Surge of BP		from baseline to 6 months

Collaborators and Investigators

• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Investigators: Principal Investigator: Stanislav E Pekarskiy, MD, Institute of Cardiology, Siberian Branch of the Russian Academy of Medical Sciences

Publications and helpful links

General Publications

• S. Pekarskiy, A. Baev, V. Mordovin, T. Ripp, G. Semke, V. Lichikaki, E. Sitkova, A. Krylov, S. Popov, R. Karpov, Renal denervation by endocardial ablation system, European Heart Journal, Volume 34, Issue suppl_1, 1 August 2013, 3788, https://doi.org/10.1093/eurheartj/eht309.3788
• Ripp TM, Mordovin VF, Pekarskiy SE, Ryabova TR, Zlobina MV, Baev AE, Anfinogenova Y, Popov SV. Predictors of Renal Denervation Efficacy in the Treatment of Resistant Hypertension. Curr Hypertens Rep. 2015 Dec;17(12):90. doi: 10.1007/s11906-015-0603-8.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: December 20, 2011
• First Submitted That Met QC Criteria: December 22, 2011
• First Posted (Estimate): December 26, 2011

Study Record Updates

• Last Update Posted (Actual): October 28, 2021
• Last Update Submitted That Met QC Criteria: October 4, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Hypertension; Renal Artery; Radiofrequency Catheter Ablation; Sympathetic Nerve Block
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED