Skip to main content
OpenTrials
Completed

NCT Number: NCT02667912

Distal Renal Denervation

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tomsk National Research Medical Center of the Russian Academy of Sciences

Tomsk, 634009, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

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

Primary outcomes

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

    Time frame: From baseline to 6 months

Secondary outcomes

  1. Number of Adverse Events

    Time frame: From baseline to 6 months

  2. Number of Adverse Events

    Time frame: From baseline to 12 months

  3. Changes of Arterial Resistance Index Measured by Doppler Flowmetry in the Right Segmental Renal Arteries

    Time frame: From baseline to 6 months

    Resistance index is calculated as the relative difference between a peak systolic and end diastolic blood flow velocities assessed by ultrasound Doppler flowmetry

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

    Time frame: From baseline to 6 months

    Resistance index calculated as the relative difference between a peak systolic and end diastolic blood flow velocities assessed by ultrasound Doppler flowmetry

  5. Changes of Serum Creatinine

    Time frame: From baseline to 6 months

  6. Changes of Serum Creatinine

    Time frame: From baseline to 12 months

  7. Changes of Estimated Glomerular Filtration Rate (eGFR)

    Time frame: From baseline to 6 months

  8. Changes of Estimated Glomerular Filtration Rate (eGFR)

    Time frame: From baseline to 12 months

  9. Changes of 24h-mean Diastolic BP

    Time frame: From baseline to 6 months

  10. Changes of 24h-mean Systolic BP

    Time frame: From baseline to 12 months

  11. Changes of 24h-mean Diastolic BP

    Time frame: From baseline to 12 months

  12. Changes of Office Systolic BP

    Time frame: From baseline to 6 months

  13. Changes of Office Systolic BP

    Time frame: From baseline to 12 months

  14. Changes of Office Diastolic BP

    Time frame: From baseline to 6 months

  15. Changes of Office Diastolic BP

    Time frame: From baseline to 12 months

  16. Changes of Daytime Systolic BP

    Time frame: From baseline to 6 months

  17. Changes of Daytime Mean Systolic BP

    Time frame: From baseline to 12 months

  18. Changes of Daytime Mean Diastolic BP

    Time frame: From baseline to 6 months

  19. Changes of Daytime Mean Diastolic BP

    Time frame: From baseline to 12 months

  20. Changes of Nighttime Mean Systolic BP

    Time frame: From baseline to 6 months

  21. Changes of Nighttime Mean Systolic BP

    Time frame: From baseline to 12 months

  22. Changes of Nighttime Mean Diastolic BP

    Time frame: From baseline to 6 months

  23. Changes of Nighttime Mean Diastolic BP

    Time frame: From baseline to 12 months

Sponsors and collaborators

Lead sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Other

Registry information

Official study title

Anatomically Optimized Distal Renal Denervation for Treatment of Resistant Hypertension

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 29, 2016
Registry last updated
Oct 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.