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
Results First Received: September 4, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hypertension
Intervention: Procedure: Bilateral radiofrequency sympathetic renal denervation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Renal Denervation  
STARTED     53  
COMPLETED     41  
NOT COMPLETED     12  
Lost to Follow-up                 10  
Protocol Violation                 1  
Withdrawal by Subject                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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


Baseline Measures
    Renal Denervation  
Number of Participants  
[units: participants]
  53  
Age  
[units: years]
Mean ± Standard Deviation
  53.8  ± 9.6  
Gender  
[units: participants]
 
Female     25  
Male     28  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     1  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     0  
White     52  
More than one race     0  
Unknown or Not Reported     0  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     0  
Not Hispanic or Latino     53  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
Russian Federation     53  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Office Systolic BP   [ Time Frame: from baseline to 12 months ]

2.  Primary:   Number of Serious Adverse Events   [ Time Frame: from baseline to 12 months ]

3.  Secondary:   Change in Office Diastolic BP   [ Time Frame: from baseline to 12 months ]

4.  Secondary:   Change in Mean 24-h Systolic BP   [ Time Frame: from baseline to 12 months ]

5.  Secondary:   Change in Mean 24-h Diastolic BP   [ Time Frame: from baseline to 12 months ]

6.  Secondary:   Change in Office Systolic BP   [ Time Frame: from baseline to 6 month ]

7.  Secondary:   Change in Office Diastolic BP   [ Time Frame: from baseline to 6 month ]

8.  Secondary:   Change in Mean 24-h Systolic BP   [ Time Frame: from baseline to 6 months ]

9.  Secondary:   Change in Mean 24-h Diastolic BP   [ Time Frame: from baseline to 6 months ]

10.  Secondary:   Change in Echocardiographic Left Ventricular Mass   [ Time Frame: from baseline to 6 months ]

11.  Secondary:   Change in Echocardiographic Left Ventricular Mass   [ Time Frame: from baseline to 12 months ]

12.  Secondary:   Change in Mean Daytime Systolic BP   [ Time Frame: from baseline to 6 months ]

13.  Secondary:   Change in Mean Daytime Diastolic BP   [ Time Frame: from baseline to 6 months ]

14.  Secondary:   Change in Mean Daytime Systolic BP   [ Time Frame: from baseline to 12 months ]

15.  Secondary:   Change in Mean Daytime Diastolic BP   [ Time Frame: from baseline to 12 months ]

16.  Secondary:   Change in Mean Nighttime Systolic BP   [ Time Frame: from baseline to 6 months ]

17.  Secondary:   Change in Mean Nighttime Diastolic BP   [ Time Frame: from baseline to 6 months ]

18.  Secondary:   Change in Mean Nighttime Systolic BP   [ Time Frame: from baseline to 12 months ]

19.  Secondary:   Change in Mean Nighttime Diastolic BP   [ Time Frame: from baseline to 12 months ]

20.  Secondary:   Change in Mean Nighttime Systolic BP Dipping   [ Time Frame: from baseline to 6 months ]

21.  Secondary:   Change in Mean Nighttime Diastolic BP Dipping   [ Time Frame: from baseline to 6 months ]

22.  Secondary:   Change in Mean Nighttime Systolic BP Dipping   [ Time Frame: from baseline to 12 months ]

23.  Secondary:   Change in Mean Nighttime Diastolic BP Dipping   [ Time Frame: from baseline to 12 months ]

24.  Secondary:   Change in Daytime Systolic BP Variability   [ Time Frame: from baseline to 12 months ]

25.  Secondary:   Change in Daytime Diastolic BP Variability   [ Time Frame: from baseline to 12 months ]

26.  Secondary:   Change in Nighttime Systolic BP Variability   [ Time Frame: from baseline to 12 months ]

27.  Secondary:   Change in Nighttime Diastolic BP Variability   [ Time Frame: from baseline to 12 months ]

28.  Secondary:   Change in Daytime Systolic BP Variability   [ Time Frame: from baseline to 6 months ]

29.  Secondary:   Change in Daytime Diastolic BP Variability   [ Time Frame: from baseline to 6 months ]

30.  Secondary:   Change in Nighttime Systolic BP Variability   [ Time Frame: from baseline to 6 months ]

31.  Secondary:   Change in Nighttime Diastolic BP Variability   [ Time Frame: from baseline to 6 months ]

32.  Secondary:   Change in Serum Creatinine   [ Time Frame: from baseline to 1 week ]

33.  Secondary:   Change in Serum Creatinine   [ Time Frame: from baseline to 6 months ]

34.  Secondary:   Change in Serum Creatinine   [ Time Frame: from baseline to 12 months ]

35.  Secondary:   Change in Casual Proteinuria   [ Time Frame: from baseline to 1 week ]

36.  Secondary:   Change in Casual Proteinuria   [ Time Frame: from baseline to 6 months ]

37.  Secondary:   Change in Casual Proteinuria   [ Time Frame: from baseline to 12 months ]

38.  Secondary:   Change in Specific Gravity of Urine   [ Time Frame: from baseline to 1 week ]

39.  Secondary:   Change in Specific Gravity of Urine   [ Time Frame: from baseline to 6 months ]

40.  Secondary:   Change in Specific Gravity of Urine   [ Time Frame: from baseline to 12 months ]

41.  Secondary:   Change in Renal Resistive Index Measured by Doppler Flowmetry in Left Main Renal Artery   [ Time Frame: from baseline to 6 months ]

42.  Secondary:   Change in Renal Resistive Index Measured by Doppler Flowmetry in Right Main Renal Artery   [ Time Frame: from baseline to 6 months ]

43.  Secondary:   Change in Resistive Index Measured by Renal Doppler Flowmetry in Left Main Renal Artery   [ Time Frame: from baseline to 12 months ]

44.  Secondary:   Change in Resistive Index Measured by Renal Doppler Flowmetry in Right Main Renal Artery   [ Time Frame: from baseline to 12 months ]

45.  Secondary:   Change in Ultrasound Intima Media Thickness of Carotid Artery   [ Time Frame: from baseline to 6 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

46.  Secondary:   Change in Ultrasound Intima Media Thickness of Carotid Artery   [ Time Frame: from baseline to 12 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

47.  Secondary:   Change in Arterial Stiffness   [ Time Frame: from baseline to 12 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

48.  Secondary:   Change in Arterial Stiffness   [ Time Frame: from baseline to 6 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

49.  Secondary:   Change in Morning Surge of BP   [ Time Frame: from baseline to 12 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

50.  Secondary:   Change in Morning Surge of BP   [ Time Frame: from baseline to 6 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Stanislav Pekarskiy
Organization: Research Institute of Cradiology, Siberian Branch of Russian Academy of Sciences
phone: +73822558122
e-mail: pekarski@cardio-tomsk.ru


No publications provided


Responsible Party: Stanislav Pekarskiy, 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