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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilateral radiofrequency sympathetic renal denervation | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Office Systolic BP | 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. | from baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Office Diastolic BP | from baseline to 12 months | |
| Change in Mean 24-h Systolic BP | from baseline to 12 months | |
| Change in Mean 24-h Diastolic BP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stanislav E Pekarskiy, MD | Institute of Cardiology, Siberian Branch of the Russian Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Cardiology, Siberian Branch of Russian Academy of Medical Sciences | Tomsk | 634012 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| 26482895 | Derived | 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. |
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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
Consecutive patients admitted to our clinic for resistant hypertension were evaluated for eligibility according to selection criteria pre-defined in protocol of this study
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| ID | Title | Description |
|---|---|---|
| FG000 | Renal Denervation | All eligible patients undergone 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) was inserted into renal artery and 4-10 point ablations were 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 was 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| 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 | Change in Office Systolic BP | All patients who completed 12 month assessment according to the protocol. | Posted | Mean | Standard Deviation | mmHg | from baseline to 12 months |
|
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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 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pospunctional pseudoaneurysm of femoral artery | Injury, poisoning and procedural complications | Systematic Assessment | Small hematoma communicating with the lumen of femoral artery occurred as a result of percutaneous punction of the femoral artery in course the procedure |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stanislav Pekarskiy | Research Institute of Cradiology, Siberian Branch of Russian Academy of Sciences | +73822558122 | pekarski@cardio-tomsk.ru |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| from baseline to 12 months |
| Change in Office Systolic BP | from baseline to 6 month |
| Change in Office Diastolic BP | from baseline to 6 month |
| Change in Mean 24-h Systolic BP | from baseline to 6 months |
| Change in Mean 24-h Diastolic BP | from baseline to 6 months |
| Change in Echocardiographic Left Ventricular Mass | from baseline to 6 months |
| Change in Echocardiographic Left Ventricular Mass | from baseline to 12 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 Daytime Systolic BP | from baseline to 12 months |
| Change in Mean Daytime Diastolic BP | from baseline to 12 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 | from baseline to 12 months |
| Change in Mean Nighttime Diastolic BP | 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 | 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 | 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 | 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 | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | from baseline to 6 months |
| Change in Serum Creatinine | from baseline to 1 week |
| Change in Serum Creatinine | from baseline to 6 months |
| Change in Serum Creatinine | from baseline to 12 months |
| Change in Casual Proteinuria | Change of protein concentration in morning urine sample | from baseline to 1 week |
| Change in Casual Proteinuria | Change of protein concentration in morning urine sample | from baseline to 6 months |
| Change in Casual Proteinuria | Change of protein concentration in morning urine sample | from baseline to 12 months |
| Change in Specific Gravity of Urine | Change of specific gravity of morning urine sample | from baseline to 1 week |
| Change in Specific Gravity of Urine | Change of specific gravity of morning urine sample | from baseline to 6 months |
| Change in Specific Gravity of Urine | 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 | 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 | 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 | 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 | 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 | from baseline to 6 months |
| Change in Ultrasound Intima Media Thickness of Carotid Artery | 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) | from baseline to 12 months |
| Change in Arterial Stiffness | 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 | from baseline to 12 months |
| Change in Morning Surge of BP | from baseline to 6 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| 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. | Posted | Number | Events | from baseline to 12 months |
|
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| Secondary | Change in Office Diastolic BP | Posted | Mean | Standard Deviation | mmHg | from baseline to 12 months |
|
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| Secondary | Change in Mean 24-h Systolic BP | Number of participants assessed at 12 months minus 1 participant with unsatisfactory ambulatory blood pressure monitoring (ABPM) record | Posted | Mean | Standard Deviation | mmHg | from baseline to 12 months |
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| Secondary | Change in Mean 24-h Diastolic BP | Number of participants assessed at 12 months minus 1 participant with unsatisfactory ABPM record | Posted | Mean | Standard Deviation | mmHg | from baseline to 12 months |
|
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| Secondary | Change in Office Systolic BP | Posted | Mean | Standard Deviation | mmHg | from baseline to 6 month |
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| Secondary | Change in Office Diastolic BP | Posted | Mean | Standard Error | mmHg | from baseline to 6 month |
|
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| Secondary | Change in Mean 24-h Systolic BP | Number of participants assessed at 6 months minus 2 participants with unsatisfactory ABPM records | Posted | Mean | Standard Deviation | mmHg | from baseline to 6 months |
|
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| Secondary | Change in Mean 24-h Diastolic BP | Number of participants assessed at 6 months minus 2 participants with unsatisfactory ABPM record | Posted | Mean | Standard Deviation | mmHg | from baseline to 6 months |
|
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| Secondary | Change in Echocardiographic Left Ventricular Mass | Number of participants assessed by echocardiography (EchoCG ) at 6 months | Posted | Mean | Standard Deviation | g | from baseline to 6 months |
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| Secondary | Change in Echocardiographic Left Ventricular Mass | Number of participants assessed by EchoCG at 12 months | Posted | Mean | Standard Deviation | g | from baseline to 12 months |
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| Secondary | Change in Mean Daytime Systolic BP | Posted | Mean | Standard Deviation | mmHg | from baseline to 6 months |
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| Secondary | Change in Mean Daytime Diastolic BP | Posted | Mean | Standard Deviation | mmHg | from baseline to 6 months |
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| Secondary | Change in Mean Daytime Systolic BP | Posted | Mean | Standard Deviation | mmHg | from baseline to 12 months |
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| Secondary | Change in Mean Daytime Diastolic BP | Posted | Mean | Standard Deviation | mmHg | from baseline to 12 months |
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| Secondary | Change in Mean Nighttime Systolic BP | Posted | Mean | Standard Deviation | mmHg | from baseline to 6 months |
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| Secondary | Change in Mean Nighttime Diastolic BP | Posted | Mean | Standard Deviation | mmHg | from baseline to 6 months |
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| Secondary | Change in Mean Nighttime Systolic BP | Posted | Mean | Standard Deviation | mmHg | from baseline to 12 months |
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| Secondary | Change in Mean Nighttime Diastolic BP | Posted | Mean | Standard Deviation | mmHg | from baseline to 12 months |
|
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| 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 | Posted | Mean | Standard Deviation | percentages | from baseline to 6 months |
|
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|
|
| 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 | Posted | Mean | Standard Deviation | percentages | from baseline to 6 months |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | difference between percentages | from baseline to 12 months |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | percentages | from baseline to 12 months |
|
|
|
|
| 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) | Posted | Mean | Standard Error | mmHg | from baseline to 12 months |
|
|
|
|
| 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 | Posted | Mean | Standard Error | mmHg | from baseline to 12 months |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | mmHg | 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 | Posted | Mean | Standard Deviation | mmHg | from baseline to 12 months |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | mmHg | from baseline to 6 months |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | mmHg | from baseline to 6 months |
|
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|
|
| 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 | Posted | Mean | Standard Deviation | mmHg | from baseline to 6 months |
|
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|
|
| 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 | Posted | Mean | Standard Deviation | mmHg | from baseline to 6 months |
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| Secondary | Change in Serum Creatinine | Posted | Mean | Standard Deviation | micromol/l | from baseline to 1 week |
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| Secondary | Change in Serum Creatinine | Posted | Mean | Standard Deviation | micromol/l | from baseline to 6 months |
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| Secondary | Change in Serum Creatinine | Posted | Mean | Standard Deviation | micromol/l | from baseline to 12 months |
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| Secondary | Change in Casual Proteinuria | Change of protein concentration in morning urine sample | Posted | Mean | Standard Deviation | g/l | from baseline to 1 week |
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| Secondary | Change in Casual Proteinuria | Change of protein concentration in morning urine sample | Posted | Mean | Standard Deviation | g/l | from baseline to 6 months |
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| Secondary | Change in Casual Proteinuria | Change of protein concentration in morning urine sample | Posted | Mean | Standard Deviation | g/l | from baseline to 12 months |
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| Secondary | Change in Specific Gravity of Urine | Change of specific gravity of morning urine sample | Posted | Mean | Standard Deviation | no specific units | from baseline to 1 week |
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| Secondary | Change in Specific Gravity of Urine | Change of specific gravity of morning urine sample | Posted | Mean | Standard Deviation | no specific units | from baseline to 6 months |
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| Secondary | Change in Specific Gravity of Urine | Change of specific gravity of morning urine sample | Posted | Mean | Standard Deviation | no specific units | from baseline to 12 months |
|
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| 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 | Posted | Mean | Standard Deviation | difference between two ratios | from baseline to 6 months |
|
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|
|
| 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 | Posted | Mean | Standard Deviation | difference between two ratios | from baseline to 6 months |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | difference between ratios | from baseline to 12 months |
|
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|
|
| 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 | Posted | Mean | Standard Deviation | difference between ratios | from baseline to 12 months |
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| Secondary | Change in Ultrasound Intima Media Thickness of Carotid Artery | Not Posted | from baseline to 6 months | Participants |
| Secondary | Change in Ultrasound Intima Media Thickness of Carotid Artery | Not Posted | from baseline to 12 months | Participants |
| Secondary | Change in Arterial Stiffness | Change of cardio-ankle vascular index(CAVI) assessed by vascular screening device VaSera VS1000 (name of the model) | Not Posted | from baseline to 12 months | Participants |
| Secondary | Change in Arterial Stiffness | Change of cardio-ankle vascular index(CAVI) assessed by vascular screening device VaSera VS1000 | Not Posted | from baseline to 6 months | Participants |
| Secondary | Change in Morning Surge of BP | Not Posted | from baseline to 12 months | Participants |
| Secondary | Change in Morning Surge of BP | Not Posted | from baseline to 6 months | Participants |
| 0 |
| 53 |
| 3 |
| 53 |
|
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