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Hypertension, Resistant to Conventional TherapyNCT02667912

Distal Renal Denervation

A study testing Distal renal denervation and Conventional renal denervation in people with Hypertension, Resistant to Conventional Therapy, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Distal renal denervation and Conventional renal denervation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteRussia
Study dates
Jan 2013to Dec 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Russia1 site

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

    Tomsk, 634009

Other trials in Russia

About this study

Official title: 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.

Read the 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.

Being tested
Distal renal denervation, Conventional renal denervation
Keywords
Hypertension, Catheter Ablation, Renal Nerves
Medical subject headings
Hypertension Resistant to Conventional Therapy, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Distal renal denervationProcedure or surgery

    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 denervationProcedure or surgery

    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

Study groups in NCT02667912
Study groupRoleWhat they receive
Distal renal denervationExperimentalEndovascular denervation of segmental branches of renal artery
Receives: Procedure: Distal renal denervation
Conventional renal denervationActive comparatorEndovascular denervation of main trunk of renal artery
Receives: Procedure: Conventional renal denervation

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: From baseline to 6 months

Secondary outcomes (23)

  1. Number of Adverse Events

    Measured: From baseline to 6 months

  2. Number of Adverse Events

    Measured: From baseline to 12 months

  3. 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

    Measured: From baseline to 6 months

  4. 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

    Measured: From baseline to 6 months

  5. Changes of Serum Creatinine

    Measured: From baseline to 6 months

  6. Changes of Serum Creatinine

    Measured: From baseline to 12 months

  7. Changes of Estimated Glomerular Filtration Rate (eGFR)

    Measured: From baseline to 6 months

  8. Changes of Estimated Glomerular Filtration Rate (eGFR)

    Measured: From baseline to 12 months

  9. Changes of 24h-mean Diastolic BP

    Measured: From baseline to 6 months

  10. Changes of 24h-mean Systolic BP

    Measured: From baseline to 12 months

  11. Changes of 24h-mean Diastolic BP

    Measured: From baseline to 12 months

  12. Changes of Office Systolic BP

    Measured: From baseline to 6 months

  13. Changes of Office Systolic BP

    Measured: From baseline to 12 months

  14. Changes of Office Diastolic BP

    Measured: From baseline to 6 months

  15. Changes of Office Diastolic BP

    Measured: From baseline to 12 months

  16. Changes of Daytime Systolic BP

    Measured: From baseline to 6 months

  17. Changes of Daytime Mean Systolic BP

    Measured: From baseline to 12 months

  18. Changes of Daytime Mean Diastolic BP

    Measured: From baseline to 6 months

  19. Changes of Daytime Mean Diastolic BP

    Measured: From baseline to 12 months

  20. Changes of Nighttime Mean Systolic BP

    Measured: From baseline to 6 months

  21. Changes of Nighttime Mean Systolic BP

    Measured: From baseline to 12 months

  22. Changes of Nighttime Mean Diastolic BP

    Measured: From baseline to 6 months

  23. Changes of Nighttime Mean Diastolic BP

    Measured: From baseline to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2016 (estimated)
  2. Study startJan 2013
  3. Primary completionJul 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02667912
Sponsor's protocol ID
022
Status last verified
Oct 2021
First submitted
26 Jan 2016
Last updated
25 Oct 2021
Data monitoring committee
No

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.

    PubMed 28005705

  • 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.

    PubMed 34806762

Questions about this trial

What is this clinical trial studying?

A study testing Distal renal denervation and Conventional renal denervation in people with Hypertension, Resistant to Conventional Therapy, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes of 24h-mean Systolic BP Assessed by Ambulatory Blood Pressure Monitoring (ABPM) (time frame: From baseline to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02667912, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.

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