Efficacy and Safety of Radiofrequency Renal Denervation in Drug Resistant Hypertension

October 4, 2021 updated by: Stanislav Pekarskiy, Tomsk National Research Medical Center of the Russian Academy of Sciences

Study of Efficacy and Safety of Radiofrequency Sympathetic Renal Denervation for Treatment of Drug Resistant Hypertension

Single-center, single group study of the efficacy and safety of transcatheter renal denervation for treatment of patients with essential hypertension uncontrolled despite combined pharmacotherapy including 3 or more hypotensive drugs one of which is a diuretic. Bilateral transcatheter renal denervation will be performed on the top of existed pharmacotherapy. Change in blood pressure (BP), left ventricle (LV) mass, carotid artery thickness, renal artery blood flow and renal function, will be assessed at 6 and 12 months of follow-up.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
53

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Tomsk, Russian Federation, 634012
        • Institute of Cardiology, Siberian Branch of Russian Academy of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 and ≤ 80 years at time of randomization
  • Informed consent
  • Treatment with full doses of 3 or more anti-hypertensive medications of different classes, of which one is a diuretic.
  • Office Systolic BP (SBP) ≥ 160 mmHg or Diastolic BP (DBP) ≥ 100 mmHg

Exclusion Criteria:

  • An estimated glomerular filtration rate (eGFR) of < 30 mL/min/1.73 m2
  • Ambulatory Blood Pressure Monitoring (ABPM) 24 hour average SBP < 135 mmHg or DBP < 85 mmHg
  • Symptomatic(secondary) hypertension
  • Severe renal artery stenosis or renal arteries abnormalities
  • Individual is pregnant, nursing or planning to be pregnant
  • Severe hepatic dysfunction
  • Any other clinically important renal, hematological, metabolic, neurological, gastrointestinal, hepatic or pulmonary disorders or dysfunctions preventing study participation (investigator's assessment)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Renal denervation
All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Procedure: Bilateral radiofrequency sympathetic renal denervation
Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways
Other Names:
  • Percutaneous radiofrequency ablation of renal nerves
  • Transcatheter renal denervation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Office Systolic BP
Time Frame: from baseline to 12 months
from baseline to 12 months
Number of Serious Adverse Events
Time Frame: from baseline to 12 months
A number of first occurrences (within the study period) of any of the following: death, end-stage renal disease, an embolic event resulting in end-organ damage, major bleeding event, renal artery thrombosis, new renal artery stenosis, other serious cardiovascular complications if their relation to the study treatment is assessed at least as possible.
from baseline to 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Office Diastolic BP
Time Frame: from baseline to 12 months
from baseline to 12 months
Change in Mean 24-h Systolic BP
Time Frame: from baseline to 12 months
from baseline to 12 months
Change in Mean 24-h Diastolic BP
Time Frame: from baseline to 12 months
from baseline to 12 months
Change in Office Systolic BP
Time Frame: from baseline to 6 month
from baseline to 6 month
Change in Office Diastolic BP
Time Frame: from baseline to 6 month
from baseline to 6 month
Change in Mean 24-h Systolic BP
Time Frame: from baseline to 6 months
from baseline to 6 months
Change in Mean 24-h Diastolic BP
Time Frame: from baseline to 6 months
from baseline to 6 months
Change in Echocardiographic Left Ventricular Mass
Time Frame: from baseline to 6 months
from baseline to 6 months
Change in Echocardiographic Left Ventricular Mass
Time Frame: from baseline to 12 months
from baseline to 12 months
Change in Mean Daytime Systolic BP
Time Frame: from baseline to 6 months
from baseline to 6 months
Change in Mean Daytime Diastolic BP
Time Frame: from baseline to 6 months
from baseline to 6 months
Change in Mean Daytime Systolic BP
Time Frame: from baseline to 12 months
from baseline to 12 months
Change in Mean Daytime Diastolic BP
Time Frame: from baseline to 12 months
from baseline to 12 months
Change in Mean Nighttime Systolic BP
Time Frame: from baseline to 6 months
from baseline to 6 months
Change in Mean Nighttime Diastolic BP
Time Frame: from baseline to 6 months
from baseline to 6 months
Change in Mean Nighttime Systolic BP
Time Frame: from baseline to 12 months
from baseline to 12 months
Change in Mean Nighttime Diastolic BP
Time Frame: from baseline to 12 months
from baseline to 12 months
Change in Mean Nighttime Systolic BP Dipping
Time Frame: from baseline to 6 months
Mean nighttime BP dipping is a relative difference: absolute difference between mean daytime and mean nighttime BP values divided by mean daytime BP value
from baseline to 6 months
Change in Mean Nighttime Diastolic BP Dipping
Time Frame: from baseline to 6 months
Mean nighttime BP dipping is a relative difference: absolute difference between mean daytime and mean nighttime BP values divided by mean daytime BP value
from baseline to 6 months
Change in Mean Nighttime Systolic BP Dipping
Time Frame: from baseline to 12 months
Mean nighttime BP dipping is a relative difference: absolute difference between mean daytime and mean nighttime BP values divided by mean daytime BP value
from baseline to 12 months
Change in Mean Nighttime Diastolic BP Dipping
Time Frame: from baseline to 12 months
Mean nighttime BP dipping is a relative difference: absolute difference between mean daytime and mean nighttime BP values divided by mean daytime BP value
from baseline to 12 months
Change in Daytime Systolic BP Variability
Time Frame: from baseline to 12 months
daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring (ABPM)
from baseline to 12 months
Change in Daytime Diastolic BP Variability
Time Frame: from baseline to 12 months
daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring
from baseline to 12 months
Change in Nighttime Systolic BP Variability
Time Frame: from baseline to 12 months
daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring
from baseline to 12 months
Change in Nighttime Diastolic BP Variability
Time Frame: from baseline to 12 months
daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring
from baseline to 12 months
Change in Daytime Systolic BP Variability
Time Frame: from baseline to 6 months
daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring
from baseline to 6 months
Change in Daytime Diastolic BP Variability
Time Frame: from baseline to 6 months
daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring
from baseline to 6 months
Change in Nighttime Systolic BP Variability
Time Frame: from baseline to 6 months
daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring
from baseline to 6 months
Change in Nighttime Diastolic BP Variability
Time Frame: from baseline to 6 months
daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring
from baseline to 6 months
Change in Serum Creatinine
Time Frame: from baseline to 1 week
from baseline to 1 week
Change in Serum Creatinine
Time Frame: from baseline to 6 months
from baseline to 6 months
Change in Serum Creatinine
Time Frame: from baseline to 12 months
from baseline to 12 months
Change in Casual Proteinuria
Time Frame: from baseline to 1 week
Change of protein concentration in morning urine sample
from baseline to 1 week
Change in Casual Proteinuria
Time Frame: from baseline to 6 months
Change of protein concentration in morning urine sample
from baseline to 6 months
Change in Casual Proteinuria
Time Frame: from baseline to 12 months
Change of protein concentration in morning urine sample
from baseline to 12 months
Change in Specific Gravity of Urine
Time Frame: from baseline to 1 week
Change of specific gravity of morning urine sample
from baseline to 1 week
Change in Specific Gravity of Urine
Time Frame: from baseline to 6 months
Change of specific gravity of morning urine sample
from baseline to 6 months
Change in Specific Gravity of Urine
Time Frame: from baseline to 12 months
Change of specific gravity of morning urine sample
from baseline to 12 months
Change in Renal Resistive Index Measured by Doppler Flowmetry in Left Main Renal Artery
Time Frame: from baseline to 6 months
Resistive index calculated as relative difference between assessed by ultrasound Doppler maximal and minimal blood flow velocities, i.e. absolute difference between maximal and minimal blood flow velocities divided by maximal flow velocity
from baseline to 6 months
Change in Renal Resistive Index Measured by Doppler Flowmetry in Right Main Renal Artery
Time Frame: from baseline to 6 months
Resistive index calculated as relative difference between assessed by ultrasound Doppler maximal and minimal blood flow velocities, i.e. absolute difference between maximal and minimal blood flow velocities divided by maximal flow velocity
from baseline to 6 months
Change in Resistive Index Measured by Renal Doppler Flowmetry in Left Main Renal Artery
Time Frame: from baseline to 12 months
Resistive index calculated as relative difference between assessed by ultrasound Doppler maximal and minimal blood flow velocities, i.e. absolute difference between maximal and minimal blood flow velocities divided by maximal flow velocity
from baseline to 12 months
Change in Resistive Index Measured by Renal Doppler Flowmetry in Right Main Renal Artery
Time Frame: from baseline to 12 months
Resistive index calculated as relative difference between assessed by ultrasound Doppler maximal and minimal blood flow velocities, i.e. absolute difference between maximal and minimal blood flow velocities divided by maximal flow velocity
from baseline to 12 months
Change in Ultrasound Intima Media Thickness of Carotid Artery
Time Frame: from baseline to 6 months
from baseline to 6 months
Change in Ultrasound Intima Media Thickness of Carotid Artery
Time Frame: from baseline to 12 months
from baseline to 12 months
Change in Arterial Stiffness
Time Frame: from baseline to 12 months
Change of cardio-ankle vascular index(CAVI) assessed by vascular screening device VaSera VS1000 (name of the model)
from baseline to 12 months
Change in Arterial Stiffness
Time Frame: from baseline to 6 months
Change of cardio-ankle vascular index(CAVI) assessed by vascular screening device VaSera VS1000
from baseline to 6 months
Change in Morning Surge of BP
Time Frame: from baseline to 12 months
from baseline to 12 months
Change in Morning Surge of BP
Time Frame: from baseline to 6 months
from baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tomsk National Research Medical Center of the Russian Academy of Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stanislav E Pekarskiy, MD, Institute of Cardiology, Siberian Branch of the Russian Academy of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 012 (Nahrain Medical Research Collective (NMRC))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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