Skip to main content
OpenTrials
Completed

NCT Number: NCT01499810

Efficacy and Safety of Radiofrequency Renal Denervation in 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Cardiology, Siberian Branch of Russian Academy of Medical Sciences

Tomsk, 634012, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Other names: Transcatheter renal denervation, Percutaneous radiofrequency ablation of renal nerves

Primary outcomes

  1. Change in Office Systolic BP

    Time frame: from baseline to 12 months

  2. Number of Serious Adverse Events

    Time frame: from baseline to 12 months

    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 outcomes

  1. Change in Office Diastolic BP

    Time frame: from baseline to 12 months

  2. Change in Mean 24-h Systolic BP

    Time frame: from baseline to 12 months

  3. Change in Mean 24-h Diastolic BP

    Time frame: from baseline to 12 months

  4. Change in Office Systolic BP

    Time frame: from baseline to 6 month

  5. Change in Office Diastolic BP

    Time frame: from baseline to 6 month

  6. Change in Mean 24-h Systolic BP

    Time frame: from baseline to 6 months

  7. Change in Mean 24-h Diastolic BP

    Time frame: from baseline to 6 months

  8. Change in Echocardiographic Left Ventricular Mass

    Time frame: from baseline to 6 months

  9. Change in Echocardiographic Left Ventricular Mass

    Time frame: from baseline to 12 months

  10. Change in Mean Daytime Systolic BP

    Time frame: from baseline to 6 months

  11. Change in Mean Daytime Diastolic BP

    Time frame: from baseline to 6 months

  12. Change in Mean Daytime Systolic BP

    Time frame: from baseline to 12 months

  13. Change in Mean Daytime Diastolic BP

    Time frame: from baseline to 12 months

  14. Change in Mean Nighttime Systolic BP

    Time frame: from baseline to 6 months

  15. Change in Mean Nighttime Diastolic BP

    Time frame: from baseline to 6 months

  16. Change in Mean Nighttime Systolic BP

    Time frame: from baseline to 12 months

  17. Change in Mean Nighttime Diastolic BP

    Time frame: from baseline to 12 months

  18. Change in Mean Nighttime Systolic BP Dipping

    Time frame: from baseline to 6 months

    Mean nighttime BP dipping is a relative difference: absolute difference between mean daytime and mean nighttime BP values divided by mean daytime BP value

  19. Change in Mean Nighttime Diastolic BP Dipping

    Time frame: from baseline to 6 months

    Mean nighttime BP dipping is a relative difference: absolute difference between mean daytime and mean nighttime BP values divided by mean daytime BP value

  20. Change in Mean Nighttime Systolic BP Dipping

    Time frame: from baseline to 12 months

    Mean nighttime BP dipping is a relative difference: absolute difference between mean daytime and mean nighttime BP values divided by mean daytime BP value

  21. Change in Mean Nighttime Diastolic BP Dipping

    Time frame: from baseline to 12 months

    Mean nighttime BP dipping is a relative difference: absolute difference between mean daytime and mean nighttime BP values divided by mean daytime BP value

  22. Change in Daytime Systolic BP Variability

    Time frame: from baseline to 12 months

    daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring (ABPM)

  23. Change in Daytime Diastolic BP Variability

    Time frame: from baseline to 12 months

    daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring

  24. Change in Nighttime Systolic BP Variability

    Time frame: from baseline to 12 months

    daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring

  25. Change in Nighttime Diastolic BP Variability

    Time frame: from baseline to 12 months

    daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring

  26. Change in Daytime Systolic BP Variability

    Time frame: from baseline to 6 months

    daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring

  27. Change in Daytime Diastolic BP Variability

    Time frame: from baseline to 6 months

    daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring

  28. Change in Nighttime Systolic BP Variability

    Time frame: from baseline to 6 months

    daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring

  29. Change in Nighttime Diastolic BP Variability

    Time frame: from baseline to 6 months

    daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring

  30. Change in Serum Creatinine

    Time frame: from baseline to 1 week

  31. Change in Serum Creatinine

    Time frame: from baseline to 6 months

  32. Change in Serum Creatinine

    Time frame: from baseline to 12 months

  33. Change in Casual Proteinuria

    Time frame: from baseline to 1 week

    Change of protein concentration in morning urine sample

  34. Change in Casual Proteinuria

    Time frame: from baseline to 6 months

    Change of protein concentration in morning urine sample

  35. Change in Casual Proteinuria

    Time frame: from baseline to 12 months

    Change of protein concentration in morning urine sample

  36. Change in Specific Gravity of Urine

    Time frame: from baseline to 1 week

    Change of specific gravity of morning urine sample

  37. Change in Specific Gravity of Urine

    Time frame: from baseline to 6 months

    Change of specific gravity of morning urine sample

  38. Change in Specific Gravity of Urine

    Time frame: from baseline to 12 months

    Change of specific gravity of morning urine sample

  39. Change in Renal Resistive Index Measured by Doppler Flowmetry in Left Main Renal Artery

    Time frame: from baseline to 6 months

    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

  40. Change in Renal Resistive Index Measured by Doppler Flowmetry in Right Main Renal Artery

    Time frame: from baseline to 6 months

    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

  41. Change in Resistive Index Measured by Renal Doppler Flowmetry in Left Main Renal Artery

    Time frame: from baseline to 12 months

    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

  42. Change in Resistive Index Measured by Renal Doppler Flowmetry in Right Main Renal Artery

    Time frame: from baseline to 12 months

    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

  43. Change in Ultrasound Intima Media Thickness of Carotid Artery

    Time frame: from baseline to 6 months

  44. Change in Ultrasound Intima Media Thickness of Carotid Artery

    Time frame: from baseline to 12 months

  45. Change in Arterial Stiffness

    Time frame: from baseline to 12 months

    Change of cardio-ankle vascular index(CAVI) assessed by vascular screening device VaSera VS1000 (name of the model)

  46. Change in Arterial Stiffness

    Time frame: from baseline to 6 months

    Change of cardio-ankle vascular index(CAVI) assessed by vascular screening device VaSera VS1000

  47. Change in Morning Surge of BP

    Time frame: from baseline to 12 months

  48. Change in Morning Surge of BP

    Time frame: from baseline to 6 months

Sponsors and collaborators

Lead sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Other

Registry information

Official study title

Study of Efficacy and Safety of Radiofrequency Sympathetic Renal Denervation for Treatment of Drug Resistant Hypertension

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Dec 26, 2011
Registry last updated
Oct 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.