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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Distal renal denervation | Experimental | Endovascular denervation of segmental branches of renal artery |
|
| Conventional renal denervation | Active Comparator | Endovascular denervation of main trunk of renal artery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of 24h-mean Systolic BP Assessed by Ambulatory Blood Pressure Monitoring (ABPM) | From baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events | From baseline to 6 months | |
| Number of Adverse Events | From baseline to 12 months | |
| Changes of Arterial Resistance Index Measured by Doppler Flowmetry in the Right Segmental Renal Arteries |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stanislav Pekarskiy, MD, PhD | Tomsk National Research Medical Center of the Russian Academy of Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tomsk National Research Medical Center of the Russian Academy of Sciences | Tomsk | 634009 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28005705 | Result | 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. | |
| 34806762 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Distal Renal Denervation | Endovascular denervation of segmental branches of renal artery |
| FG001 | Conventional Renal Denervation | Endovascular denervation of main trunk of renal artery |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Distal Renal Denervation | Endovascular denervation of segmental branches of renal artery |
| BG001 | Conventional Renal Denervation | Endovascular denervation of main trunk of renal artery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes of 24h-mean Systolic BP Assessed by Ambulatory Blood Pressure Monitoring (ABPM) | The subjects who completed 6 months follow up without serious violations of the study protocol - per protocol set | Posted | Mean | Standard Deviation | mmHg | From baseline to 6 months |
|
6 months
Serious Adverse Events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Distal Renal Denervation | Endovascular denervation of segmental branches of renal artery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post-punctional pseudoaneuryzm | Surgical and medical procedures | Non-systematic Assessment | Hemorrhage from the femoral artery at the punction site after removal of intra-arterial introducer |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stanislav Pekarskiy | Tomsk National Research Medical Center of the Russian Academy of Sciences | +73822558122 | pekarski@cardio-tomsk.ru |
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| ID | Term |
|---|---|
| C563514 | Hypertension Resistant to Conventional Therapy |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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|
| 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 |
|
Resistance index is calculated as the relative difference between a peak systolic and end diastolic blood flow velocities assessed by ultrasound Doppler flowmetry |
| From baseline to 6 months |
| 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 | From baseline to 6 months |
| Changes of Serum Creatinine | From baseline to 6 months |
| Changes of Serum Creatinine | From baseline to 12 months |
| Changes of Estimated Glomerular Filtration Rate (eGFR) | From baseline to 6 months |
| Changes of Estimated Glomerular Filtration Rate (eGFR) | From baseline to 12 months |
| Changes of 24h-mean Diastolic BP | From baseline to 6 months |
| Changes of 24h-mean Systolic BP | From baseline to 12 months |
| Changes of 24h-mean Diastolic BP | From baseline to 12 months |
| Changes of Office Systolic BP | From baseline to 6 months |
| Changes of Office Systolic BP | From baseline to 12 months |
| Changes of Office Diastolic BP | From baseline to 6 months |
| Changes of Office Diastolic BP | From baseline to 12 months |
| Changes of Daytime Systolic BP | From baseline to 6 months |
| Changes of Daytime Mean Systolic BP | From baseline to 12 months |
| Changes of Daytime Mean Diastolic BP | From baseline to 6 months |
| Changes of Daytime Mean Diastolic BP | From baseline to 12 months |
| Changes of Nighttime Mean Systolic BP | From baseline to 6 months |
| Changes of Nighttime Mean Systolic BP | From baseline to 12 months |
| Changes of Nighttime Mean Diastolic BP | From baseline to 6 months |
| Changes of Nighttime Mean Diastolic BP | From baseline to 12 months |
| 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. |
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Concomitant coronary artery disease (CAD) | Count of Participants | Participants |
|
| Concomitant diabetes | Count of Participants | Participants |
|
| A number of antihypertensive drugs taken | Mean | Standard Deviation | Medication (single active ingredient) |
|
| A use of diuretics | Count of Participants | Participants |
|
| Office systolic BP | Mean | Standard Deviation | mmHg |
|
| Office diastolic BP | Mean | Standard Deviation | mmHg |
|
| 24-hour systolic BP | Mean | Standard Deviation | mmHg |
|
| 24-hour diastolic BP | Mean | Standard Deviation | mmHg |
|
| Left ventricular mass | Mean | Standard Deviation | g |
|
| 24-hour proteinuria | Mean | Standard Deviation | g |
|
| Serum creatinine | Mean | Standard Deviation | mMol/L |
|
| estimated glomerular filtration rate (eGFR) | Glomerular filtration rate estimated using Modification of Diet in Renal Disease (MDRD) Study formula | Mean | Standard Deviation | ml/min/m2 |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Number of Adverse Events | Posted | Number | adverse event | From baseline to 6 months |
|
|
|
| Secondary | Number of Adverse Events | A baseline population except those who refused to continue in the study before final assessment and thereby whose status was unknown at 12 months follow up (5 in the distal denervation arm and 3 patients in conventional denervation arm). | Posted | Number | adverse event | From baseline to 12 months |
|
|
|
| Secondary | 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 | Per protocol set (PPS) | Posted | Mean | Standard Deviation | ratio | From baseline to 6 months |
|
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | ratio | From baseline to 6 months |
|
|
|
|
| Secondary | Changes of Serum Creatinine | Posted | Mean | Standard Deviation | μmol/l | From baseline to 6 months |
|
|
|
|
| Secondary | Changes of Serum Creatinine | Intention-to-treat (ITT) analysis by Last Observation Carried Forward (LOCF) method. (Six month data were used in 4 late (>6 months) dropouts and also in 1 patient without 12 month' ABPM, 1 month data were used in 2 early (<6 months) dropouts. One patient had no post procedure data at all and was excluded from analysis) | Posted | Mean | Standard Error | μmol/l | From baseline to 12 months |
|
|
|
|
| Secondary | Changes of Estimated Glomerular Filtration Rate (eGFR) | The subjects with available data | Posted | Mean | Standard Deviation | ml/min/square meter | From baseline to 6 months |
|
|
|
| Secondary | Changes of Estimated Glomerular Filtration Rate (eGFR) | ITT analysis by Last Observation Carried Forward (LOCF) method in the subjects with the available data. (Six month data were used in 4 late (>6 months) dropouts and also in 1 patient without 12 month' ABPM, 1 month data were used in 2 early (<6 months) dropouts. One patient had no post procedure data at all and was excluded from analysis) | Posted | Mean | Standard Deviation | ml/min/square meter | From baseline to 12 months |
|
|
|
| Secondary | Changes of 24h-mean Diastolic BP | PPS | Posted | Mean | Standard Deviation | mmHg | From baseline to 6 months |
|
|
|
|
| Secondary | Changes of 24h-mean Systolic BP | ITT analysis by Last Observation Carried Forward (LOCF) method in the subjects with the available data . (Six month data were used in 4 late (>6 months) dropouts and also in 1 patient without 12 month' ABPM, 1 month data were used in 2 early (<6 months) dropouts. One patient had no post procedure data at all and was excluded from analysis) | Posted | Mean | Standard Deviation | mmHg | From baseline to 12 months |
|
|
|
|
| Secondary | Changes of 24h-mean Diastolic BP | ITT analysis by Last Observation Carried Forward (LOCF) method in the subjects with the available data . (Six month data were used in 4 late (>6 months) dropouts and also in 1 patient without 12 month' ABPM, 1 month data were used in 2 early (<6 months) dropouts. One patient had no post procedure data at all and was excluded from analysis) | Posted | Mean | Standard Deviation | mmHg | From baseline to 12 months |
|
|
|
|
| Secondary | Changes of Office Systolic BP | PPS | Posted | Mean | Standard Deviation | mmHg | From baseline to 6 months |
|
|
|
|
| Secondary | Changes of Office Systolic BP | ITT analysis by Last Observation Carried Forward (LOCF) method in the subjects with the available data . (Six month data were used in 4 late (>6 months) dropouts and also in 1 patient without 12 month' ABPM, 1 month data were used in 2 early (<6 months) dropouts. One patient had no post procedure data at all and was excluded from analysis) | Posted | Mean | Standard Deviation | mmHg | From baseline to 12 months |
|
|
|
|
| Secondary | Changes of Office Diastolic BP | PPS | Posted | Mean | Standard Deviation | mmHg | From baseline to 6 months |
|
|
|
|
| Secondary | Changes of Office Diastolic BP | Posted | Mean | Standard Deviation | mmHg | From baseline to 12 months |
|
|
|
|
| Secondary | Changes of Daytime Systolic BP | PPS | Posted | Mean | Standard Deviation | mmHg | From baseline to 6 months |
|
|
|
|
| Secondary | Changes of Daytime Mean Systolic BP | ITT analysis by Last Observation Carried Forward (LOCF) method. (Six month data were used in 4 late (>6 months) dropouts and also in 1 patient without 12 month' ABPM, 1 month data were used in 2 early (<6 months) dropouts. One patient had no post procedure data at all and was excluded from analysis) | Posted | Mean | Standard Deviation | mmHg | From baseline to 12 months |
|
|
|
|
| Secondary | Changes of Daytime Mean Diastolic BP | PPS | Posted | Mean | Standard Deviation | mmHg | From baseline to 6 months |
|
|
|
|
| Secondary | Changes of Daytime Mean Diastolic BP | ITT analysis by Last Observation Carried Forward (LOCF). (Six month data were used in 4 late (>6 months) dropouts and also in 1 patient without 12 month' ABPM, 1 month data were used in 2 early (<6 months) dropouts. One patient had no post procedure data at all and was excluded from analysis) | Posted | Mean | Standard Deviation | mmHg | From baseline to 12 months |
|
|
|
|
| Secondary | Changes of Nighttime Mean Systolic BP | PPS | Posted | Mean | Standard Deviation | mmHg | From baseline to 6 months |
|
|
|
|
| Secondary | Changes of Nighttime Mean Systolic BP | ITT analysis by Last Observation Carried Forward (LOCF) method in the subjects with the available data. (Six month data were used in 4 late (>6 months) dropouts and also in 1 patient without 12 month' ABPM, 1 month data were used in 2 early (<6 months) dropouts. One patient had no post procedure data at all and was excluded from analysis) | Posted | Mean | Standard Deviation | mmHg | From baseline to 12 months |
|
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|
|
| Secondary | Changes of Nighttime Mean Diastolic BP | PPS | Posted | Mean | Standard Deviation | mmHg | From baseline to 6 months |
|
|
|
|
| Secondary | Changes of Nighttime Mean Diastolic BP | ITT analysis by Last Observation Carried Forward (LOCF) method in the subjects with the available data. (6 month data were used in 4 late (>6 months) dropouts and also in 1 patient without 12 month' ABPM, 1 month data were used in 2 early (<6 months) dropouts. One patient had no post procedure data at all and was excluded from analysis) | Posted | Mean | Standard Deviation | mmHg | From baseline to 12 months |
|
|
|
|
| 1 |
| 27 |
| 0 |
| 27 |
| EG001 | Conventional Renal Denervation | Endovascular denervation of main trunk of renal artery | 0 | 24 | 0 | 24 |
|
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