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
  Purpose

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.


Condition Intervention Phase
Hypertension
Procedure: Bilateral radiofrequency sympathetic renal denervation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Efficacy and Safety of Radiofrequency Sympathetic Renal Denervation for Treatment of Drug Resistant Hypertension

Resource links provided by NLM:


Further study details as provided by Russian Academy of Medical Sciences:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 53
Study Start Date: March 2010
Study Completion Date: January 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01499810

Locations
Russian Federation
Institute of Cardiology, Siberian Branch of Russian Academy of Medical Sciences
Tomsk, Russian Federation, 634012
Sponsors and Collaborators
Russian Academy of Medical Sciences
Investigators
Principal Investigator: Stanislav E Pekarskiy, MD Institute of Cardiology, Siberian Branch of the Russian Academy of Medical Sciences
  More Information

No publications provided

Responsible Party: Stanislav Pekarskiy, Principal Investigator, Federal State Budgetary Institution "Research Institute for Сardiology" of Siberian Branch under the Russian Academy of Medical Sciences, Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01499810     History of Changes
Other Study ID Numbers: 012
Study First Received: December 20, 2011
Results First Received: September 4, 2014
Last Updated: September 16, 2014
Health Authority: Russia: Federal Service on Surveillance in Healthcare and Social Development

Keywords provided by Russian Academy of Medical Sciences:
Hypertension
Radiofrequency Catheter Ablation
Renal Artery
Sympathetic Nerve Block

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 28, 2014