Distal Renal Denervation

NCT ID: NCT02667912

Last Updated: 2021-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2016-12-31

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.

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.

Conditions

Hypertension, Resistant to Conventional Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Distal renal denervation

Endovascular denervation of segmental branches of renal artery

Group Type: EXPERIMENTAL

Distal renal denervation

Intervention Type: 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

Conventional renal denervation

Endovascular denervation of main trunk of renal artery

Group Type: ACTIVE_COMPARATOR

Conventional renal denervation

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tomsk National Research Medical Center of the Russian Academy of Sciences

OTHER

Sponsor Role: lead

Responsible Party

Stanislav Pekarskiy

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stanislav Pekarskiy, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tomsk National Research Medical Center of the Russian Academy of Sciences

Locations

Tomsk National Research Medical Center of the Russian Academy of Sciences

Tomsk, , Russia

Countries

Russia

References

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.

Reference Type: RESULT

PMID: 28005705 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34806762 (View on PubMed)

Other Identifiers

022

Identifier Type: -

Identifier Source: org_study_id