Hypertension
Conditions
Keywords
Hypertension, Radiofrequency Catheter Ablation, Renal Artery, Sympathetic Nerve Block
Brief 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. 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.
Interventions
PROCEDUREBilateral 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
Sponsors
Tomsk National Research Medical Center of the Russian Academy of Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Office Systolic BP | from baseline to 12 months | — |
| Number of Serious Adverse Events | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean 24-h Diastolic BP | from baseline to 12 months | — |
| Change in Office Systolic BP | from baseline to 6 month | — |
| Change in Echocardiographic Left Ventricular Mass | from baseline to 6 months | — |
| Change in Mean Daytime Systolic BP | from baseline to 6 months | — |
| Change in Mean Daytime Diastolic BP | from baseline to 6 months | — |
| Change in Mean Nighttime Systolic BP | from baseline to 6 months | — |
| Change in Mean Nighttime Diastolic BP | from baseline to 6 months | — |
| Change in Mean Nighttime Systolic BP Dipping | 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 |
| Change in Mean Nighttime Diastolic BP Dipping | 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 |
| Change in Daytime Systolic BP Variability | 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) |
| Change in Daytime Diastolic BP Variability | 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 |
| Change in Office Diastolic BP | from baseline to 12 months | — |
| Change in Nighttime Diastolic BP Variability | 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 |
| Change in Serum Creatinine | from baseline to 1 week | — |
| Change in Casual Proteinuria | from baseline to 1 week | Change of protein concentration in morning urine sample |
| Change in Specific Gravity of Urine | from baseline to 1 week | Change of specific gravity of morning urine sample |
| Change in Renal Resistive Index Measured by Doppler Flowmetry in Left Main Renal Artery | 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 |
| Change in Renal Resistive Index Measured by Doppler Flowmetry in Right Main Renal Artery | 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 |
| Change in Resistive Index Measured by Renal Doppler Flowmetry in Left Main Renal Artery | 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 |
| Change in Resistive Index Measured by Renal Doppler Flowmetry in Right Main Renal Artery | 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 |
| Change in Ultrasound Intima Media Thickness of Carotid Artery | from baseline to 6 months | — |
| Change in Arterial Stiffness | from baseline to 12 months | Change of cardio-ankle vascular index(CAVI) assessed by vascular screening device VaSera VS1000 (name of the model) |
| Change in Morning Surge of BP | from baseline to 12 months | — |
| Change in Nighttime Systolic BP Variability | 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 |
| Change in Mean 24-h Systolic BP | from baseline to 12 months | — |
Countries
Russia
Participant flow
Recruitment details
Consecutive patients admitted to our clinic for resistant hypertension were evaluated for eligibility according to selection criteria pre-defined in protocol of this study
Pre-assignment details
83 patients with true resistant hypertension were identified, 12 rejected the intervention, 11 were excluded for anatomical reasons: atherosclerosis of renal arteries - 7, multiple narrow renal arteries - 2, fibromuscular dysplasia (FMD) - 1 and aneurysm of renal artery - 1. Finally 53 subjects were included and undergone renal denervation
Participants by arm
| Arm | Count |
|---|---|
| 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.
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 | 53 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 10 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Renal Denervation |
|---|---|
| Age, Continuous | 53.8 years STANDARD_DEVIATION 9.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 52 Participants |
| Region of Enrollment Russian Federation | 53 participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 53 |
| serious Total, serious adverse events | 0 / 53 |
Outcome results
Primary
Change in Office Systolic BP
Time frame: from baseline to 12 months
Population: All patients who completed 12 month assessment according to the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Office Systolic BP | -31.1 mmHg | Standard Deviation 24 |
Comparison: Repeated measures analysisp-value: <0.0001t-test, 2 sided
Primary
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.
Time frame: from baseline to 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Renal Denervation | Number of Serious Adverse Events | 0 Events |
Secondary
Change in Arterial Stiffness
Change of cardio-ankle vascular index(CAVI) assessed by vascular screening device VaSera VS1000 (name of the model)
Time frame: from baseline to 12 months
Secondary
Change in Arterial Stiffness
Change of cardio-ankle vascular index(CAVI) assessed by vascular screening device VaSera VS1000
Time frame: from baseline to 6 months
Secondary
Change in Casual Proteinuria
Change of protein concentration in morning urine sample
Time frame: from baseline to 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Casual Proteinuria | -0.04 g/l | Standard Deviation 0.2 |
Comparison: Repeated measures analysisp-value: 0.29t-test, 2 sided
Secondary
Change in Casual Proteinuria
Change of protein concentration in morning urine sample
Time frame: from baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Casual Proteinuria | -0.005 g/l | Standard Deviation 0.2 |
Comparison: Repeated measures analysisp-value: 0.89t-test, 2 sided
Secondary
Change in Casual Proteinuria
Change of protein concentration in morning urine sample
Time frame: from baseline to 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Casual Proteinuria | 0.05 g/l | Standard Deviation 0.09 |
Comparison: Repeated measures analysisp-value: 0.65t-test, 2 sided
Secondary
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
Time frame: from baseline to 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Daytime Diastolic BP Variability | -1.0 mmHg | Standard Error 3.3 |
Comparison: Repeated measures analysisp-value: 0.07t-test, 2 sided
Secondary
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
Time frame: from baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Daytime Diastolic BP Variability | 0.4 mmHg | Standard Deviation 3 |
Comparison: Repeated measures analysisp-value: 0.37t-test, 2 sided
Secondary
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
Time frame: from baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Daytime Systolic BP Variability | -0.2 mmHg | Standard Deviation 4.3 |
Comparison: Repeated measures analysisp-value: 0.72t-test, 2 sided
Secondary
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)
Time frame: from baseline to 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Daytime Systolic BP Variability | -1.4 mmHg | Standard Error 4.5 |
Comparison: Repeated measures analysisp-value: 0.06t-test, 2 sided
Secondary
Change in Echocardiographic Left Ventricular Mass
Time frame: from baseline to 12 months
Population: Number of participants assessed by EchoCG at 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Echocardiographic Left Ventricular Mass | -14.6 g | Standard Deviation 61.4 |
Comparison: Repeated measures analysisp-value: 0.12t-test, 2 sided
Secondary
Change in Echocardiographic Left Ventricular Mass
Time frame: from baseline to 6 months
Population: Number of participants assessed by echocardiography (EchoCG ) at 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Echocardiographic Left Ventricular Mass | -10.1 g | Standard Deviation 71.3 |
Comparison: Repeated measures analysisp-value: 0.35t-test, 2 sided
Secondary
Change in Mean 24-h Diastolic BP
Time frame: from baseline to 12 months
Population: Number of participants assessed at 12 months minus 1 participant with unsatisfactory ABPM record
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Mean 24-h Diastolic BP | -7.6 mmHg | Standard Deviation 10.1 |
Comparison: Repeated measures analysisp-value: <0.0001t-test, 2 sided
Secondary
Change in Mean 24-h Diastolic BP
Time frame: from baseline to 6 months
Population: Number of participants assessed at 6 months minus 2 participants with unsatisfactory ABPM record
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Mean 24-h Diastolic BP | -6.2 mmHg | Standard Deviation 9 |
Comparison: Repeated measures analysisp-value: <0.0001t-test, 2 sided
Secondary
Change in Mean 24-h Systolic BP
Time frame: from baseline to 12 months
Population: Number of participants assessed at 12 months minus 1 participant with unsatisfactory ambulatory blood pressure monitoring (ABPM) record
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Mean 24-h Systolic BP | -11.9 mmHg | Standard Deviation 15.9 |
Comparison: Repeated measures analysisp-value: <0.0001t-test, 2 sided
Secondary
Change in Mean 24-h Systolic BP
Time frame: from baseline to 6 months
Population: Number of participants assessed at 6 months minus 2 participants with unsatisfactory ABPM records
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Mean 24-h Systolic BP | -10.3 mmHg | Standard Deviation 15.3 |
Comparison: Repeated measures analysisp-value: 0.0001t-test, 2 sided
Secondary
Change in Mean Daytime Diastolic BP
Time frame: from baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Mean Daytime Diastolic BP | -6.7 mmHg | Standard Deviation 10.2 |
Comparison: Repeated measures analysisp-value: 0.00009t-test, 2 sided
Secondary
Change in Mean Daytime Diastolic BP
Time frame: from baseline to 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Mean Daytime Diastolic BP | -7.7 mmHg | Standard Deviation 11.4 |
Comparison: Repeated measures analysisp-value: 0.0001t-test, 2 sided
Secondary
Change in Mean Daytime Systolic BP
Time frame: from baseline to 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Mean Daytime Systolic BP | -12.3 mmHg | Standard Deviation 16.7 |
Comparison: Repeated measures analysisp-value: 0.00004t-test, 2 sided
Secondary
Change in Mean Daytime Systolic BP
Time frame: from baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Mean Daytime Systolic BP | -11.0 mmHg | Standard Deviation 16.5 |
Comparison: Repeated measures analysisp-value: 0.00007t-test, 2 sided
Secondary
Change in Mean Nighttime Diastolic BP
Time frame: from baseline to 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Mean Nighttime Diastolic BP | -7.3 mmHg | Standard Deviation 11.1 |
Comparison: Repeated measures analysisp-value: 0.0002t-test, 2 sided
Secondary
Change in Mean Nighttime Diastolic BP
Time frame: from baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Mean Nighttime Diastolic BP | -5.0 mmHg | Standard Deviation 9.5 |
Comparison: Repeated measures analysisp-value: 0.001t-test, 2 sided
Secondary
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
Time frame: from baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Mean Nighttime Diastolic BP Dipping | -1.1 percentages | Standard Deviation 9 |
Comparison: Repeated measures analysisp-value: 0.54t-test, 2 sided
Secondary
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
Time frame: from baseline to 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Mean Nighttime Diastolic BP Dipping | 0.47 percentages | Standard Deviation 10.23 |
Comparison: Repeated measures analysisp-value: 0.77t-test, 2 sided
Secondary
Change in Mean Nighttime Systolic BP
Time frame: from baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Mean Nighttime Systolic BP | -9.2 mmHg | Standard Deviation 16.7 |
Comparison: Repeated measures analysisp-value: 0.0007t-test, 2 sided
Secondary
Change in Mean Nighttime Systolic BP
Time frame: from baseline to 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Mean Nighttime Systolic BP | -11.2 mmHg | Standard Deviation 18.3 |
Comparison: Repeated measures analysisp-value: 0.0004t-test, 2 sided
Secondary
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
Time frame: from baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Mean Nighttime Systolic BP Dipping | -0.4 percentages | Standard Deviation 8.3 |
Comparison: Repeated measures analysisp-value: 0.57t-test, 2 sided
Secondary
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
Time frame: from baseline to 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Mean Nighttime Systolic BP Dipping | -0.23 difference between percentages | Standard Deviation 8.73 |
Comparison: Repeated measures analysisp-value: 0.87t-test, 2 sided
Secondary
Change in Morning Surge of BP
Time frame: from baseline to 6 months
Secondary
Change in Morning Surge of BP
Time frame: from baseline to 12 months
Secondary
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
Time frame: from baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Nighttime Diastolic BP Variability | 0.2 mmHg | Standard Deviation 4.8 |
Comparison: Repeated measures analysisp-value: 0.76t-test, 2 sided
Secondary
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
Time frame: from baseline to 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Nighttime Diastolic BP Variability | -1.03 mmHg | Standard Deviation 4.13 |
Comparison: Repeated measures analysisp-value: 0.12t-test, 2 sided
Secondary
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
Time frame: from baseline to 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Nighttime Systolic BP Variability | -0.83 mmHg | Standard Deviation 5.27 |
Comparison: Repeated measures analysisp-value: 0.32t-test, 2 sided
Secondary
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
Time frame: from baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Nighttime Systolic BP Variability | -0.01 mmHg | Standard Deviation 5 |
Comparison: Repeated measures analysisp-value: 0.99t-test, 2 sided
Secondary
Change in Office Diastolic BP
Time frame: from baseline to 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Office Diastolic BP | -15.4 mmHg | Standard Deviation 15.6 |
Comparison: Repeated measures analysisp-value: <0.0001t-test, 2 sided
Secondary
Change in Office Diastolic BP
Time frame: from baseline to 6 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Office Diastolic BP | -13.3 mmHg | Standard Error 15.7 |
Comparison: Repeated measures analysisp-value: <0.0001t-test, 2 sided
Secondary
Change in Office Systolic BP
Time frame: from baseline to 6 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Office Systolic BP | -27.1 mmHg | Standard Deviation 24.8 |
Comparison: Repeated measures analysisp-value: <0.0001t-test, 2 sided
Secondary
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
Time frame: from baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Renal Resistive Index Measured by Doppler Flowmetry in Left Main Renal Artery | -0.008 difference between two ratios | Standard Deviation 0.055 |
Comparison: Repeated measures analysisp-value: 0.32t-test, 2 sided
Secondary
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
Time frame: from baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Renal Resistive Index Measured by Doppler Flowmetry in Right Main Renal Artery | 0.010 difference between two ratios | Standard Deviation 0.075 |
Comparison: Repeated measures analysisp-value: 0.4t-test, 2 sided
Secondary
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
Time frame: from baseline to 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Resistive Index Measured by Renal Doppler Flowmetry in Left Main Renal Artery | -0.011 difference between ratios | Standard Deviation 0.06 |
Comparison: Repeated measures analysisp-value: 0.17t-test, 2 sided
Secondary
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
Time frame: from baseline to 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Resistive Index Measured by Renal Doppler Flowmetry in Right Main Renal Artery | -0.019 difference between ratios | Standard Deviation 0.07 |
Comparison: Repeated measures analysisp-value: 0.014t-test, 2 sided
Secondary
Change in Serum Creatinine
Time frame: from baseline to 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Serum Creatinine | 2.4 micromol/l | Standard Deviation 9.8 |
Comparison: Repeated measures analysisp-value: 0.08t-test, 2 sided
Secondary
Change in Serum Creatinine
Time frame: from baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Serum Creatinine | -1.6 micromol/l | Standard Deviation 11.3 |
Comparison: Repeated measures analysisp-value: 0.35t-test, 2 sided
Secondary
Change in Serum Creatinine
Time frame: from baseline to 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Serum Creatinine | 1.9 micromol/l | Standard Deviation 13.9 |
Comparison: Repeated measures analysisp-value: 0.22t-test, 2 sided
Secondary
Change in Specific Gravity of Urine
Change of specific gravity of morning urine sample
Time frame: from baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Specific Gravity of Urine | 1.0 no specific units | Standard Deviation 7.1 |
Comparison: Repeated measures analysisp-value: 0.35t-test, 2 sided
Secondary
Change in Specific Gravity of Urine
Change of specific gravity of morning urine sample
Time frame: from baseline to 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Specific Gravity of Urine | -0.38 no specific units | Standard Deviation 7.9 |
Comparison: Repeated measures analysisp-value: 0.76t-test, 2 sided
Secondary
Change in Specific Gravity of Urine
Change of specific gravity of morning urine sample
Time frame: from baseline to 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Specific Gravity of Urine | -0.07 no specific units | Standard Deviation 5.7 |
Comparison: Repeated measures analysisp-value: 0.92t-test, 2 sided
Secondary
Change in Ultrasound Intima Media Thickness of Carotid Artery
Time frame: from baseline to 12 months
Secondary
Change in Ultrasound Intima Media Thickness of Carotid Artery
Time frame: from baseline to 6 months