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Efficacy and Safety of Radiofrequency Renal Denervation in Drug Resistant Hypertension

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stanislav Pekarskiy, Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01499810
First received: December 20, 2011
Last updated: November 20, 2012
Last verified: November 2012
History of Changes
  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: Single Blind (Subject)
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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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-ankle 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-ankle 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 ]

Estimated Enrollment: 30
Study Start Date: March 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 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
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
Last Updated: November 20, 2012
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
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013