Status:
COMPLETED
Efficacy and Safety of Radiofrequency Renal Denervation in Drug Resistant Hypertension
Lead Sponsor:
Tomsk National Research Medical Center of the Russian Academy of Sciences
Conditions:
Hypertension
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 incl...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT01499810
Start Date
March 1 2010
End Date
January 1 2014
Last Update
October 28 2021
Active Locations (1)
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1
Institute of Cardiology, Siberian Branch of Russian Academy of Medical Sciences
Tomsk, Russia, 634012