Efficacy and Safety of Radiofrequency Renal Denervation in Drug Resistant Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stanislav Pekarskiy, Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01499810
First received: December 20, 2011
Last updated: September 16, 2014
Last verified: September 2014

December 20, 2011
September 16, 2014
March 2010
December 2013   (final data collection date for primary outcome measure)
  • Change in Office Systolic BP [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: No ]
  • Number of Serious Adverse Events [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: Yes ]
    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.
  • Change in office BP [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: No ]
  • Number of Serious Adverse Events [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01499810 on ClinicalTrials.gov Archive Site
  • Change in Office Diastolic BP [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: No ]
  • Change in Mean 24-h Systolic BP [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: No ]
  • Change in Mean 24-h Diastolic BP [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: No ]
  • Change in Office Systolic BP [ Time Frame: from baseline to 6 month ] [ Designated as safety issue: No ]
  • Change in Office Diastolic BP [ Time Frame: from baseline to 6 month ] [ Designated as safety issue: No ]
  • Change in Mean 24-h Systolic BP [ Time Frame: from baseline to 6 months ] [ Designated as safety issue: No ]
  • Change in Mean 24-h Diastolic BP [ Time Frame: from baseline to 6 months ] [ Designated as safety issue: No ]
  • Change in Echocardiographic Left Ventricular Mass [ Time Frame: from baseline to 6 months ] [ Designated as safety issue: No ]
  • Change in Echocardiographic Left Ventricular Mass [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: No ]
  • Change in Mean Daytime Systolic BP [ Time Frame: from baseline to 6 months ] [ Designated as safety issue: No ]
  • Change in Mean Daytime Diastolic BP [ Time Frame: from baseline to 6 months ] [ Designated as safety issue: No ]
  • Change in Mean Daytime Systolic BP [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: No ]
  • Change in Mean Daytime Diastolic BP [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: No ]
  • Change in Mean Nighttime Systolic BP [ Time Frame: from baseline to 6 months ] [ Designated as safety issue: No ]
  • Change in Mean Nighttime Diastolic BP [ Time Frame: from baseline to 6 months ] [ Designated as safety issue: No ]
  • Change in Mean Nighttime Systolic BP [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: No ]
  • Change in Mean Nighttime Diastolic BP [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: No ]
  • Change in Mean Nighttime Systolic BP Dipping [ Time Frame: from baseline to 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: from baseline to 6 months ] [ Designated as safety issue: No ]
    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 Systolic BP Dipping [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: No ]
    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 Nighttime Systolic BP Variability [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: No ]
    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 Nighttime Diastolic BP Variability [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: No ]
    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 Daytime Systolic BP Variability [ Time Frame: from baseline to 6 months ] [ Designated as safety issue: No ]
    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 Daytime Diastolic BP Variability [ Time Frame: from baseline to 6 months ] [ Designated as safety issue: No ]
    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 Nighttime Systolic BP Variability [ Time Frame: from baseline to 6 months ] [ Designated as safety issue: No ]
    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 Nighttime Diastolic BP Variability [ Time Frame: from baseline to 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: from baseline to 1 week ] [ Designated as safety issue: Yes ]
  • Change in Serum Creatinine [ Time Frame: from baseline to 6 months ] [ Designated as safety issue: Yes ]
  • Change in Serum Creatinine [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: Yes ]
  • Change in Casual Proteinuria [ Time Frame: from baseline to 1 week ] [ Designated as safety issue: Yes ]
    Change of protein concentration in morning urine sample
  • Change in Casual Proteinuria [ Time Frame: from baseline to 6 months ] [ Designated as safety issue: Yes ]
    Change of protein concentration in morning urine sample
  • Change in Casual Proteinuria [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: Yes ]
    Change of protein concentration in morning urine sample
  • Change in Specific Gravity of Urine [ Time Frame: from baseline to 1 week ] [ Designated as safety issue: Yes ]
    Change of specific gravity of morning urine sample
  • Change in Specific Gravity of Urine [ Time Frame: from baseline to 6 months ] [ Designated as safety issue: Yes ]
    Change of specific gravity of morning urine sample
  • Change in Specific Gravity of Urine [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: Yes ]
    Change of specific gravity of morning urine sample
  • Change in Renal Resistive Index Measured by Doppler Flowmetry in Left Main Renal Artery [ Time Frame: from baseline to 6 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: from baseline to 6 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: from baseline to 6 months ] [ Designated as safety issue: No ]
  • Change in Ultrasound Intima Media Thickness of Carotid Artery [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: No ]
  • Change in Arterial Stiffness [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: No ]
    Change of cardio-ankle vascular index(CAVI) assessed by vascular screening device VaSera VS1000 (name of the model)
  • Change in Arterial Stiffness [ Time Frame: from baseline to 6 months ] [ Designated as safety issue: No ]
    Change of cardio-ankle vascular index(CAVI) assessed by vascular screening device VaSera VS1000
  • Change in Morning Surge of BP [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: No ]
  • Change in Morning Surge of BP [ Time Frame: from baseline to 6 months ] [ Designated as safety issue: No ]
  • Change in office BP [ Time Frame: from baseline to 6 month ] [ Designated as safety issue: No ]
  • Change in mean 24-h BP [ Time Frame: from baseline to 6 months ] [ Designated as safety issue: No ]
  • Change in mean 24-h BP [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: No ]
  • Change in mean daytime BP [ Time Frame: from baseline to 6 months ] [ Designated as safety issue: No ]
  • Change in mean daytime BP [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: No ]
  • Change in mean nighttime BP [ Time Frame: from baseline to 6 months ] [ Designated as safety issue: No ]
  • Change in mean nighttime BP [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: No ]
  • Change in mean nighttime BP dipping [ Time Frame: from baseline to 6 months ] [ Designated as safety issue: No ]
  • Change in mean nighttime BP dipping [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: No ]
  • Change in morning surge of BP [ Time Frame: from baseline to 6 months ] [ Designated as safety issue: No ]
  • Change in morning surge of BP [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: No ]
  • Change in daytime BP variability [ Time Frame: from baseline to 6 months ] [ Designated as safety issue: No ]
  • Change in daytime BP variability [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: No ]
  • Change in nighttime BP variability [ Time Frame: from baseline to 6 months ] [ Designated as safety issue: No ]
  • Change in nighttime BP variability [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: No ]
  • Change in serum creatinine [ Time Frame: from baseline to 1 week ] [ Designated as safety issue: Yes ]
  • Change in serum creatinine [ Time Frame: from baseline to 6 months ] [ Designated as safety issue: Yes ]
  • Change in serum creatinine [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: Yes ]
  • Change in casual proteinuria [ Time Frame: from baseline to 1 week ] [ Designated as safety issue: Yes ]
    Change of protein concentration in morning urine sample
  • Change in casual proteinuria [ Time Frame: from baseline to 6 months ] [ Designated as safety issue: Yes ]
    Change of protein concentration in morning urine sample
  • Change in casual proteinuria [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: Yes ]
    Change of protein concentration in morning urine sample
  • Change in specific gravity of urine [ Time Frame: from baseline to 1 week ] [ Designated as safety issue: Yes ]
    Change of specific gravity of morning urine sample
  • Change in specific gravity of urine [ Time Frame: from baseline to 6 months ] [ Designated as safety issue: Yes ]
    Change of specific gravity of morning urine sample
  • Change in specific gravity of urine [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: Yes ]
    Change of specific gravity of morning urine sample
  • Change in renal Doppler flowmetry (RDF) [ Time Frame: from baseline to 6 months ] [ Designated as safety issue: Yes ]
    Change of mean, maximal velocity and resistive index of blood flow in renal artery
  • Change in renal Doppler flowmetry (RDF) [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: Yes ]
    Change of mean, maximal velocity and resistive index of blood flow in renal artery
  • Change in arterial stiffness [ Time Frame: from baseline to 6 months ] [ Designated as safety issue: No ]
    Change of cardio-ancle vascular index(CAVI) assessed by vascular screening device VaSera VS1000
  • Change in arterial stiffness [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: No ]
    Change of cardio-ancle vascular index(CAVI) assessed by vascular screening device VaSera VS1000
  • Change in echocardiographic Left Ventricular Mass Index [ Time Frame: from baseline to 6 months ] [ Designated as safety issue: No ]
  • Change in echocardiographic Left Ventricular Mass Index [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: No ]
  • Change in ultrasound intima media thickness of carotid artery [ Time Frame: from baseline to 6 months ] [ Designated as safety issue: No ]
  • Change in ultrasound intima media thickness of carotid artery [ Time Frame: from baseline to 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy and Safety of Radiofrequency Renal Denervation in Drug Resistant Hypertension
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.

Not Provided
Interventional
Phase 2
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
Procedure: Bilateral radiofrequency sympathetic renal denervation
Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways
Other Names:
  • Transcatheter renal denervation
  • Percutaneous radiofrequency ablation of renal nerves
Experimental: Renal denervation
All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.
Intervention: Procedure: Bilateral radiofrequency sympathetic renal denervation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
January 2014
December 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT01499810
012
No
Stanislav Pekarskiy, Russian Academy of Medical Sciences
Russian Academy of Medical Sciences
Not Provided
Principal Investigator: Stanislav E Pekarskiy, MD Institute of Cardiology, Siberian Branch of the Russian Academy of Medical Sciences
Russian Academy of Medical Sciences
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP