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Efficacy and Safety of Radiofrequency Renal Denervation in Drug Resistant Hypertension

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ClinicalTrials.gov Identifier: NCT01499810
Recruitment Status : Completed
First Posted : December 26, 2011
Results First Posted : September 17, 2014
Last Update Posted : February 26, 2016
Sponsor:
Information provided by (Responsible Party):
Stanislav Pekarskiy, Federal State Budgetary Scientific Institution, Research Institute of Cardiology

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Hypertension
Intervention: Procedure: Bilateral radiofrequency sympathetic renal denervation

  Participant Flow

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

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 
Overall Participants Analyzed 
[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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Stanislav Pekarskiy, Federal State Budgetary Scientific Institution, Research Institute of Cardiology
ClinicalTrials.gov Identifier: NCT01499810     History of Changes
Other Study ID Numbers: 012
First Submitted: December 20, 2011
First Posted: December 26, 2011
Results First Submitted: September 4, 2014
Results First Posted: September 17, 2014
Last Update Posted: February 26, 2016