Distal Renal Denervation

Anatomically Optimized Distal Renal Denervation for Treatment of Resistant Hypertension

Objective of this study is to evaluate whether a distal mode of endovascular renal denervation with the treatment performed primarily in segmental branches of renal artery is more effective than conventional mode of the intervention with the treatment equally distributed within its main trunk for the treatment of drug-resistant hypertension.

Study Overview

• Status: Completed
• Conditions: Hypertension, Resistant to Conventional Therapy
• Intervention / Treatment: Procedure: Distal renal denervation; Procedure: Conventional renal denervation

Detailed Description

Recent spectacular failure of renal denervation (RDN) therapy in SymplicityHTN-3 trial in fact might be easily predicted from the very beginning. Conventional RDN done as 4-6 point treatments equally distributed within main trunk of renal artery (RA) may only be effective if renal plexus tightly surrounds the artery throughout its whole course with equal longitudinal and circumferential density of the nerve fibers. While this idea itself is unnaturally idealistic also a number of surgical studies demonstrated that proximally majority of renal nerves go at a distance from RA obliquely to its course and join the artery mainly in its distal part (fan-shaped renal plexus with wide base directed toward aorta and apex converging to renal gate). We developed a distal mode of RDN targeting segmental branches of RA and conducted a single-center double-blind randomized controlled parallel group study to compare its efficacy and safety to those of conventional RDN in patients with drug-resistant hypertension.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Tomsk, Russian Federation, 634009
    • Tomsk National Research Medical Center of the Russian Academy of 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:

• systolic BP is equal or greater than 160 mmHg or diastolic BP is equal or greater than 100 mmHg,
• stable (>3 months) treatment with full doses of at least 3 antihypertensive drugs including a diuretic,
• given written informed consent

Exclusion Criteria:

• secondary hypertension
• 24h-mean systolic BP <135 mmHg,
• estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2,
• extended disease of renal artery,
• any other clinically important disorders/comorbidities significantly increasing risk of endovascular intervention (investigator's assessment)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Distal renal denervation; Endovascular denervation of segmental branches of renal artery	Procedure: Distal renal denervation; Percutaneous endovascular intervention when catheter-based electrode (Symplicity Flex; Medtronic, Inc.) is used for stepwise radiofrequency energy delivery to segmental branches of the renal artery in a number of points distributed along the length and circumference of the vessels in order to ablate renal nerve plexus
Active Comparator: Conventional renal denervation; Endovascular denervation of main trunk of renal artery	Procedure: Conventional renal denervation; Percutaneous endovascular intervention when catheter-based electrode (Symplicity Flex; Medtronic, Inc.) is used for stepwise radiofrequency energy delivery to the main trunk of the renal artery in a number of points equally distributed along its length and circumference in order to ablate renal nerve plexus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes of 24h-mean Systolic BP Assessed by Ambulatory Blood Pressure Monitoring (ABPM)	From baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Adverse Events		From baseline to 6 months
Number of Adverse Events		From baseline to 12 months
Changes of Arterial Resistance Index Measured by Doppler Flowmetry in the Right Segmental Renal Arteries	Resistance index is calculated as the relative difference between a peak systolic and end diastolic blood flow velocities assessed by ultrasound Doppler flowmetry	From baseline to 6 months
Changes of Arterial Resistance Index Measured by Doppler Flowmetry in the Left Segmental Renal Arteries	Resistance index calculated as the relative difference between a peak systolic and end diastolic blood flow velocities assessed by ultrasound Doppler flowmetry	From baseline to 6 months
Changes of Serum Creatinine		From baseline to 6 months
Changes of Serum Creatinine		From baseline to 12 months
Changes of Estimated Glomerular Filtration Rate (eGFR)		From baseline to 6 months
Changes of Estimated Glomerular Filtration Rate (eGFR)		From baseline to 12 months
Changes of 24h-mean Diastolic BP		From baseline to 6 months
Changes of 24h-mean Systolic BP		From baseline to 12 months
Changes of 24h-mean Diastolic BP		From baseline to 12 months
Changes of Office Systolic BP		From baseline to 6 months
Changes of Office Systolic BP		From baseline to 12 months
Changes of Office Diastolic BP		From baseline to 6 months
Changes of Office Diastolic BP		From baseline to 12 months
Changes of Daytime Systolic BP		From baseline to 6 months
Changes of Daytime Mean Systolic BP		From baseline to 12 months
Changes of Daytime Mean Diastolic BP		From baseline to 6 months
Changes of Daytime Mean Diastolic BP		From baseline to 12 months
Changes of Nighttime Mean Systolic BP		From baseline to 6 months
Changes of Nighttime Mean Systolic BP		From baseline to 12 months
Changes of Nighttime Mean Diastolic BP		From baseline to 6 months
Changes of Nighttime Mean Diastolic BP		From baseline to 12 months

Collaborators and Investigators

• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Investigators: Principal Investigator: Stanislav Pekarskiy, MD, PhD, Tomsk National Research Medical Center of the Russian Academy of Sciences

Publications and helpful links

General Publications

• Pekarskiy SE, Baev AE, Mordovin VF, Semke GV, Ripp TM, Falkovskaya AU, Lichikaki VA, Sitkova ES, Zubanova IV, Popov SV. Denervation of the distal renal arterial branches vs. conventional main renal artery treatment: a randomized controlled trial for treatment of resistant hypertension. J Hypertens. 2017 Feb;35(2):369-375. doi: 10.1097/HJH.0000000000001160.
• Pisano A, Iannone LF, Leo A, Russo E, Coppolino G, Bolignano D. Renal denervation for resistant hypertension. Cochrane Database Syst Rev. 2021 Nov 22;11(11):CD011499. doi: 10.1002/14651858.CD011499.pub3.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: January 26, 2016
• First Submitted That Met QC Criteria: January 26, 2016
• First Posted (Estimate): January 29, 2016

Study Record Updates

• Last Update Posted (Actual): October 25, 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, Catheter Ablation, Renal Nerves
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 022 (ITCC)