Distal Renal Denervation

NCT02667912 | Completed Results

• 1 other identifier: 022
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension, Resistant to Conventional Therapy

Keywords

Hypertension, Catheter Ablation, Renal Nerves

Outcome Measures

Primary Outcomes (1)

• Changes of 24h-mean Systolic BP Assessed by Ambulatory Blood Pressure Monitoring (ABPM)

  From baseline to 6 months

Secondary Outcomes (23)

• 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

  From baseline to 6 months

• Changes of Arterial Resistance Index Measured by Doppler Flowmetry in the Left Segmental Renal Arteries

  From baseline to 6 months

• Changes of Serum Creatinine

  From baseline to 6 months

Study Arms (2)

Distal renal denervation

EXPERIMENTAL

Endovascular denervation of segmental branches of renal artery

Procedure: Distal renal denervation

Conventional renal denervation

ACTIVE COMPARATOR

Endovascular denervation of main trunk of renal artery

Procedure: Conventional renal denervation

Interventions

Distal renal denervation PROCEDURE

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

Distal renal denervation

Conventional renal denervation PROCEDURE

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

Conventional renal denervation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• secondary hypertension
• h-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)

Sponsors & Collaborators

• Tomsk National Research Medical Center of the Russian Academy of Sciences: lead

Study Sites (1)

Tomsk National Research Medical Center of the Russian Academy of Sciences

Tomsk, 634009, Russia

Location

Related Publications (2)

• 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.

  PMID: 28005705 RESULT

• 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.

  PMID: 34806762 DERIVED

MeSH Terms

Conditions

Hypertension Resistant to Conventional Therapy; Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Stanislav Pekarskiy
• Organization: Tomsk National Research Medical Center of the Russian Academy of Sciences

pekarski@cardio-tomsk.ru

+73822558122

Study Officials

• Stanislav Pekarskiy, MD, PhD

  Tomsk National Research Medical Center of the Russian Academy of Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 26, 2016
• First Posted: January 29, 2016
• Study Start: January 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 25, 2021
• Results First Posted: February 1, 2019

Record last verified: 2021-10

Locations

RU (1)