Efficacy and Safety of Radiofrequency Renal Denervation in Drug Resistant Hypertension

Study of Efficacy and Safety of Radiofrequency Sympathetic Renal Denervation for Treatment of 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.

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)