Clinical trial NCT01499810: Efficacy and Safety of Radiofrequency Renal Denervation in Drug Resistant Hypertension
Official title: Study of Efficacy and Safety of Radiofrequency Sympathetic Renal Denervation for Treatment of Drug Resistant Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Radiofrequency Catheter Ablation
Renal Artery
Sympathetic Nerve Block
Lead sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
Sponsor class: OTHER
First posted: 2011-12-26
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.


Eligibility 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)

Primary outcomes:
measure: Change in Office Systolic BP
timeFrame: from baseline to 12 months
measure: Number of Serious Adverse Events
timeFrame: from baseline to 12 months
Secondary outcomes:
measure: Change in Office Diastolic BP
timeFrame: from baseline to 12 months
measure: Change in Mean 24-h Systolic BP
timeFrame: from baseline to 12 months
measure: Change in Mean 24-h Diastolic BP
timeFrame: from baseline to 12 months
measure: Change in Office Systolic BP
timeFrame: from baseline to 6 month
measure: Change in Office Diastolic BP
timeFrame: from baseline to 6 month
measure: Change in Mean 24-h Systolic BP
timeFrame: from baseline to 6 months
measure: Change in Mean 24-h Diastolic BP
timeFrame: from baseline to 6 months
measure: Change in Echocardiographic Left Ventricular Mass
timeFrame: from baseline to 6 months
measure: Change in Echocardiographic Left Ventricular Mass
timeFrame: from baseline to 12 months
measure: Change in Mean Daytime Systolic BP
timeFrame: from baseline to 6 months
measure: Change in Mean Daytime Diastolic BP
timeFrame: from baseline to 6 months
measure: Change in Mean Daytime Systolic BP
timeFrame: from baseline to 12 months
measure: Change in Mean Daytime Diastolic BP
timeFrame: from baseline to 12 months
measure: Change in Mean Nighttime Systolic BP
timeFrame: from baseline to 6 months
measure: Change in Mean Nighttime Diastolic BP
timeFrame: from baseline to 6 months
measure: Change in Mean Nighttime Systolic BP
timeFrame: from baseline to 12 months
measure: Change in Mean Nighttime Diastolic BP
timeFrame: from baseline to 12 months
measure: Change in Mean Nighttime Systolic BP Dipping
timeFrame: from baseline to 6 months
measure: Change in Mean Nighttime Diastolic BP Dipping
timeFrame: from baseline to 6 months
measure: Change in Mean Nighttime Systolic BP Dipping
timeFrame: from baseline to 12 months
measure: Change in Mean Nighttime Diastolic BP Dipping
timeFrame: from baseline to 12 months
measure: Change in Daytime Systolic BP Variability
timeFrame: from baseline to 12 months
measure: Change in Daytime Diastolic BP Variability
timeFrame: from baseline to 12 months
measure: Change in Nighttime Systolic BP Variability
timeFrame: from baseline to 12 months
measure: Change in Nighttime Diastolic BP Variability
timeFrame: from baseline to 12 months
measure: Change in Daytime Systolic BP Variability
timeFrame: from baseline to 6 months
measure: Change in Daytime Diastolic BP Variability
timeFrame: from baseline to 6 months
measure: Change in Nighttime Systolic BP Variability
timeFrame: from baseline to 6 months
measure: Change in Nighttime Diastolic BP Variability
timeFrame: from baseline to 6 months
measure: Change in Serum Creatinine
timeFrame: from baseline to 1 week
measure: Change in Serum Creatinine
timeFrame: from baseline to 6 months
measure: Change in Serum Creatinine
timeFrame: from baseline to 12 months
measure: Change in Casual Proteinuria
timeFrame: from baseline to 1 week
measure: Change in Casual Proteinuria
timeFrame: from baseline to 6 months
measure: Change in Casual Proteinuria
timeFrame: from baseline to 12 months
measure: Change in Specific Gravity of Urine
timeFrame: from baseline to 1 week
measure: Change in Specific Gravity of Urine
timeFrame: from baseline to 6 months
measure: Change in Specific Gravity of Urine
timeFrame: from baseline to 12 months
measure: Change in Renal Resistive Index Measured by Doppler Flowmetry in Left Main Renal Artery
timeFrame: from baseline to 6 months
measure: Change in Renal Resistive Index Measured by Doppler Flowmetry in Right Main Renal Artery
timeFrame: from baseline to 6 months
measure: Change in Resistive Index Measured by Renal Doppler Flowmetry in Left Main Renal Artery
timeFrame: from baseline to 12 months
measure: Change in Resistive Index Measured by Renal Doppler Flowmetry in Right Main Renal Artery
timeFrame: from baseline to 12 months
measure: Change in Ultrasound Intima Media Thickness of Carotid Artery
timeFrame: from baseline to 6 months
measure: Change in Ultrasound Intima Media Thickness of Carotid Artery
timeFrame: from baseline to 12 months
measure: Change in Arterial Stiffness
timeFrame: from baseline to 12 months
measure: Change in Arterial Stiffness
timeFrame: from baseline to 6 months
measure: Change in Morning Surge of BP
timeFrame: from baseline to 12 months
measure: Change in Morning Surge of BP
timeFrame: from baseline to 6 months
Other outcomes:
Locations:
city: Tomsk
country: Russian Federation
facility: Institute of Cardiology, Siberian Branch of Russian Academy of Medical Sciences
Study officials:
affiliation: Institute of Cardiology, Siberian Branch of the Russian Academy of Medical Sciences
name: Stanislav E Pekarskiy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: S. Pekarskiy, A. Baev, V. Mordovin, T. Ripp, G. Semke, V. Lichikaki, E. Sitkova, A. Krylov, S. Popov, R. Karpov, Renal denervation by endocardial ablation system, European Heart Journal, Volume 34, Issue suppl_1, 1 August 2013, 3788, https://doi.org/10.1093/eurheartj/eht309.3788
citation: Ripp TM, Mordovin VF, Pekarskiy SE, Ryabova TR, Zlobina MV, Baev AE, Anfinogenova Y, Popov SV. Predictors of Renal Denervation Efficacy in the Treatment of Resistant Hypertension. Curr Hypertens Rep. 2015 Dec;17(12):90. doi: 10.1007/s11906-015-0603-8.