HypertensionNCT01499810
Efficacy and Safety of Radiofrequency Renal Denervation in Drug Resistant Hypertension
A study testing Bilateral radiofrequency sympathetic renal denervation in people with Hypertension, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Bilateral radiofrequency sympathetic renal denervation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteRussia
- Study dates
- Mar 2010to Jan 2014
- 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
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Russia1 site
Institute of Cardiology, Siberian Branch of Russian Academy of Medical Sciences
Tomsk, 634012
About this study
Official title: 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.
- Conditions
- Hypertension
- Being tested
- Bilateral radiofrequency sympathetic renal denervation
- Keywords
- Hypertension, Radiofrequency Catheter Ablation, Renal Artery, Sympathetic Nerve Block
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral radiofrequency sympathetic renal denervationProcedure or surgery
Also called Transcatheter renal denervation, Percutaneous radiofrequency ablation of renal nerves
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
| Study group | Role | What they receive |
|---|---|---|
| Renal denervation | Experimental | 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. Receives: Procedure: Bilateral radiofrequency sympathetic renal denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Office Systolic BP
Measured: from baseline to 12 months
Number of Serious Adverse Events
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.
Measured: from baseline to 12 months
Secondary outcomes (48)
Change in Office Diastolic BP
Measured: from baseline to 12 months
Change in Mean 24-h Systolic BP
Measured: from baseline to 12 months
Change in Mean 24-h Diastolic BP
Measured: from baseline to 12 months
Change in Office Systolic BP
Measured: from baseline to 6 month
Change in Office Diastolic BP
Measured: from baseline to 6 month
Change in Mean 24-h Systolic BP
Measured: from baseline to 6 months
Change in Mean 24-h Diastolic BP
Measured: from baseline to 6 months
Change in Echocardiographic Left Ventricular Mass
Measured: from baseline to 6 months
Change in Echocardiographic Left Ventricular Mass
Measured: from baseline to 12 months
Change in Mean Daytime Systolic BP
Measured: from baseline to 6 months
Change in Mean Daytime Diastolic BP
Measured: from baseline to 6 months
Change in Mean Daytime Systolic BP
Measured: from baseline to 12 months
Change in Mean Daytime Diastolic BP
Measured: from baseline to 12 months
Change in Mean Nighttime Systolic BP
Measured: from baseline to 6 months
Change in Mean Nighttime Diastolic BP
Measured: from baseline to 6 months
Change in Mean Nighttime Systolic BP
Measured: from baseline to 12 months
Change in Mean Nighttime Diastolic BP
Measured: from baseline to 12 months
Change in Mean Nighttime Systolic BP Dipping
Mean nighttime BP dipping is a relative difference: absolute difference between mean daytime and mean nighttime BP values divided by mean daytime BP value
Measured: from baseline to 6 months
Change in Mean Nighttime Diastolic BP Dipping
Mean nighttime BP dipping is a relative difference: absolute difference between mean daytime and mean nighttime BP values divided by mean daytime BP value
Measured: from baseline to 6 months
Change in Mean Nighttime Systolic BP Dipping
Mean nighttime BP dipping is a relative difference: absolute difference between mean daytime and mean nighttime BP values divided by mean daytime BP value
Measured: from baseline to 12 months
Change in Mean Nighttime Diastolic BP Dipping
Mean nighttime BP dipping is a relative difference: absolute difference between mean daytime and mean nighttime BP values divided by mean daytime BP value
Measured: from baseline to 12 months
Change in Daytime Systolic BP Variability
daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring (ABPM)
Measured: from baseline to 12 months
Change in Daytime Diastolic BP Variability
daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring
Measured: from baseline to 12 months
Change in Nighttime Systolic BP Variability
daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring
Measured: from baseline to 12 months
Change in Nighttime Diastolic BP Variability
daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring
Measured: from baseline to 12 months
Change in Daytime Systolic BP Variability
daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring
Measured: from baseline to 6 months
Change in Daytime Diastolic BP Variability
daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring
Measured: from baseline to 6 months
Change in Nighttime Systolic BP Variability
daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring
Measured: from baseline to 6 months
Change in Nighttime Diastolic BP Variability
daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring
Measured: from baseline to 6 months
Change in Serum Creatinine
Measured: from baseline to 1 week
Change in Serum Creatinine
Measured: from baseline to 6 months
Change in Serum Creatinine
Measured: from baseline to 12 months
Change in Casual Proteinuria
Change of protein concentration in morning urine sample
Measured: from baseline to 1 week
Change in Casual Proteinuria
Change of protein concentration in morning urine sample
Measured: from baseline to 6 months
Change in Casual Proteinuria
Change of protein concentration in morning urine sample
Measured: from baseline to 12 months
Change in Specific Gravity of Urine
Change of specific gravity of morning urine sample
Measured: from baseline to 1 week
Change in Specific Gravity of Urine
Change of specific gravity of morning urine sample
Measured: from baseline to 6 months
Change in Specific Gravity of Urine
Change of specific gravity of morning urine sample
Measured: from baseline to 12 months
Change in Renal Resistive Index Measured by Doppler Flowmetry in Left Main Renal Artery
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
Measured: from baseline to 6 months
Change in Renal Resistive Index Measured by Doppler Flowmetry in Right Main Renal Artery
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
Measured: from baseline to 6 months
Change in Resistive Index Measured by Renal Doppler Flowmetry in Left Main Renal Artery
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
Measured: from baseline to 12 months
Change in Resistive Index Measured by Renal Doppler Flowmetry in Right Main Renal Artery
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
Measured: from baseline to 12 months
Change in Ultrasound Intima Media Thickness of Carotid Artery
Measured: from baseline to 6 months
Change in Ultrasound Intima Media Thickness of Carotid Artery
Measured: from baseline to 12 months
Change in Arterial Stiffness
Change of cardio-ankle vascular index(CAVI) assessed by vascular screening device VaSera VS1000 (name of the model)
Measured: from baseline to 12 months
Change in Arterial Stiffness
Change of cardio-ankle vascular index(CAVI) assessed by vascular screening device VaSera VS1000
Measured: from baseline to 6 months
Change in Morning Surge of BP
Measured: from baseline to 12 months
Change in Morning Surge of BP
Measured: from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startMar 2010
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stanislav Pekarskiy, Tomsk National Research Medical Center of the Russian Academy of Sciences
- Investigators
- Stanislav E Pekarskiy, MD, Principal investigator, Institute of Cardiology, Siberian Branch of the Russian Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01499810
- Sponsor's protocol ID
- 012
- Status last verified
- Oct 2021
- First submitted
- 20 Dec 2011
- Last updated
- 28 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
S. Pekarskiy, A. Baev, V. Mordovin, T. Ripp, G. Semke, V. Lichikaki, E. Sitkova, A. Krylov, S. Popov, R. Karpov, Renal denervation by endocardial ablation system, European Heart Journal, Volume 34, Issue suppl_1, 1 August 2013, 3788, https://doi.org/10.1093/eurheartj/eht309.3788
Ripp TM, Mordovin VF, Pekarskiy SE, Ryabova TR, Zlobina MV, Baev AE, Anfinogenova Y, Popov SV. Predictors of Renal Denervation Efficacy in the Treatment of Resistant Hypertension. Curr Hypertens Rep. 2015 Dec;17(12):90. doi: 10.1007/s11906-015-0603-8.
PubMed 26482895
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Efficacy and Safety of Radiofrequency Sympathetic Renal Denervation for Treatment of Drug Resistant Hypertension
- ClinicalTrials.gov ID
- NCT01499810
- Acronym / sponsor ID
- 012
- Conditions
- Hypertension
- Keywords
- Hypertension, Radiofrequency Catheter Ablation, Renal Artery, Sympathetic Nerve Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of SciencesUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 26 Dec 2011 (estimated)
- Results
- Posted 17 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal denervation | Experimental | Procedure: Bilateral radiofrequency sympathetic renal denervationAll 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral radiofrequency sympathetic renal denervationAlso: Transcatheter renal denervation, Percutaneous radiofrequency ablation of renal nervesBilateral 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 | Procedure or surgery | Renal denervation |
Primary outcome
Change in Office Systolic BP
Time frame: 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.
48 secondary outcomes
Change in Office Diastolic BP
Time frame: from baseline to 12 months
Change in Mean 24-h Systolic BP
Time frame: from baseline to 12 months
Change in Mean 24-h Diastolic BP
Time frame: from baseline to 12 months
Change in Office Systolic BP
Time frame: from baseline to 6 month
Change in Office Diastolic BP
Time frame: from baseline to 6 month
Change in Mean 24-h Systolic BP
Time frame: from baseline to 6 months
Change in Mean 24-h Diastolic BP
Time frame: from baseline to 6 months
Change in Echocardiographic Left Ventricular Mass
Time frame: from baseline to 6 months
Change in Echocardiographic Left Ventricular Mass
Time frame: from baseline to 12 months
Change in Mean Daytime Systolic BP
Time frame: from baseline to 6 months
Change in Mean Daytime Diastolic BP
Time frame: from baseline to 6 months
Change in Mean Daytime Systolic BP
Time frame: from baseline to 12 months
Change in Mean Daytime Diastolic BP
Time frame: from baseline to 12 months
Change in Mean Nighttime Systolic BP
Time frame: from baseline to 6 months
Change in Mean Nighttime Diastolic BP
Time frame: from baseline to 6 months
Change in Mean Nighttime Systolic BP
Time frame: from baseline to 12 months
Change in Mean Nighttime Diastolic BP
Time frame: from baseline to 12 months
Change in Mean Nighttime Systolic BP Dipping
Time frame: from baseline to 6 months
Change in Mean Nighttime Diastolic BP Dipping
Time frame: from baseline to 6 months
Change in Mean Nighttime Systolic BP Dipping
Time frame: from baseline to 12 months
Change in Mean Nighttime Diastolic BP Dipping
Time frame: from baseline to 12 months
Change in Daytime Systolic BP Variability
Time frame: from baseline to 12 months
Change in Daytime Diastolic BP Variability
Time frame: from baseline to 12 months
Change in Nighttime Systolic BP Variability
Time frame: from baseline to 12 months
Change in Nighttime Diastolic BP Variability
Time frame: from baseline to 12 months
Change in Daytime Systolic BP Variability
Time frame: from baseline to 6 months
Change in Daytime Diastolic BP Variability
Time frame: from baseline to 6 months
Change in Nighttime Systolic BP Variability
Time frame: from baseline to 6 months
Change in Nighttime Diastolic BP Variability
Time frame: from baseline to 6 months
Change in Serum Creatinine
Time frame: from baseline to 1 week
Change in Serum Creatinine
Time frame: from baseline to 6 months
Change in Serum Creatinine
Time frame: from baseline to 12 months
Change in Casual Proteinuria
Time frame: from baseline to 1 week
Change in Casual Proteinuria
Time frame: from baseline to 6 months
Change in Casual Proteinuria
Time frame: from baseline to 12 months
Change in Specific Gravity of Urine
Time frame: from baseline to 1 week
Change in Specific Gravity of Urine
Time frame: from baseline to 6 months
Change in Specific Gravity of Urine
Time frame: 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
Change in Renal Resistive Index Measured by Doppler Flowmetry in Right Main Renal Artery
Time frame: from baseline to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundS. Pekarskiy, A. Baev, V. Mordovin, T. Ripp, G. Semke, V. Lichikaki, E. Sitkova, A. Krylov, S. Popov, R. Karpov, Renal denervation by endocardial ablation system, European Heart Journal, Volume 34, Issue suppl_1, 1 August 2013, 3788, https://doi.org/10.1093/eurheartj/eht309.3788
- Derived from this study: PubMed 26482895Ripp TM, Mordovin VF, Pekarskiy SE, Ryabova TR, Zlobina MV, Baev AE, Anfinogenova Y, Popov SV. Predictors of Renal Denervation Efficacy in the Treatment of Resistant Hypertension. Curr Hypertens Rep. 2015 Dec;17(12):90. doi: 10.1007/s11906-015-0603-8.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stanislav E Pekarskiy, MD principal investigator
Institute of Cardiology, Siberian Branch of the Russian Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral radiofrequency sympathetic renal denervation in people with Hypertension, 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 4 inclusion and 7 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 28 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 17 Sep 2014). 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?
Change in Office Systolic BP (time frame: from baseline to 12 months). The study lists 2 primary outcomes in all. 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 NCT01499810, 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 28 Oct 2021.