Efficacy and Safety of Radiofrequency Renal Denervation in Drug Resistant Hypertension

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01499810
• Other study ID #: 012
• Status: Completed
• Phase: N/A
• Start date: March 2010
• Est. completion date: January 2014

Study information

• Verified date: October 2021
• Source: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hypertension

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Institute of Cardiology, Siberian Branch of Russian Academy of Medical Sciences	Tomsk

Sponsors (1)

Lead Sponsor	Collaborator
Tomsk National Research Medical Center of the Russian Academy of Sciences

Country where clinical trial is conducted

Russian Federation, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Office Systolic BP		from baseline to 12 months
Primary	Number of Serious Adverse Events	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.	from baseline to 12 months
Secondary	Change in Office Diastolic BP		from baseline to 12 months
Secondary	Change in Mean 24-h Systolic BP		from baseline to 12 months
Secondary	Change in Mean 24-h Diastolic BP		from baseline to 12 months
Secondary	Change in Office Systolic BP		from baseline to 6 month
Secondary	Change in Office Diastolic BP		from baseline to 6 month
Secondary	Change in Mean 24-h Systolic BP		from baseline to 6 months
Secondary	Change in Mean 24-h Diastolic BP		from baseline to 6 months
Secondary	Change in Echocardiographic Left Ventricular Mass		from baseline to 6 months
Secondary	Change in Echocardiographic Left Ventricular Mass		from baseline to 12 months
Secondary	Change in Mean Daytime Systolic BP		from baseline to 6 months
Secondary	Change in Mean Daytime Diastolic BP		from baseline to 6 months
Secondary	Change in Mean Daytime Systolic BP		from baseline to 12 months
Secondary	Change in Mean Daytime Diastolic BP		from baseline to 12 months
Secondary	Change in Mean Nighttime Systolic BP		from baseline to 6 months
Secondary	Change in Mean Nighttime Diastolic BP		from baseline to 6 months
Secondary	Change in Mean Nighttime Systolic BP		from baseline to 12 months
Secondary	Change in Mean Nighttime Diastolic BP		from baseline to 12 months
Secondary	Change in Mean Nighttime Systolic BP Dipping	Mean nighttime BP dipping is a relative difference: absolute difference between mean daytime and mean nighttime BP values divided by mean daytime BP value	from baseline to 6 months
Secondary	Change in Mean Nighttime Diastolic BP Dipping	Mean nighttime BP dipping is a relative difference: absolute difference between mean daytime and mean nighttime BP values divided by mean daytime BP value	from baseline to 6 months
Secondary	Change in Mean Nighttime Systolic BP Dipping	Mean nighttime BP dipping is a relative difference: absolute difference between mean daytime and mean nighttime BP values divided by mean daytime BP value	from baseline to 12 months
Secondary	Change in Mean Nighttime Diastolic BP Dipping	Mean nighttime BP dipping is a relative difference: absolute difference between mean daytime and mean nighttime BP values divided by mean daytime BP value	from baseline to 12 months
Secondary	Change in Daytime Systolic BP Variability	daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring (ABPM)	from baseline to 12 months
Secondary	Change in Daytime Diastolic BP Variability	daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring	from baseline to 12 months
Secondary	Change in Nighttime Systolic BP Variability	daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring	from baseline to 12 months
Secondary	Change in Nighttime Diastolic BP Variability	daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring	from baseline to 12 months
Secondary	Change in Daytime Systolic BP Variability	daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring	from baseline to 6 months
Secondary	Change in Daytime Diastolic BP Variability	daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring	from baseline to 6 months
Secondary	Change in Nighttime Systolic BP Variability	daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring	from baseline to 6 months
Secondary	Change in Nighttime Diastolic BP Variability	daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring	from baseline to 6 months
Secondary	Change in Serum Creatinine		from baseline to 1 week
Secondary	Change in Serum Creatinine		from baseline to 6 months
Secondary	Change in Serum Creatinine		from baseline to 12 months
Secondary	Change in Casual Proteinuria	Change of protein concentration in morning urine sample	from baseline to 1 week
Secondary	Change in Casual Proteinuria	Change of protein concentration in morning urine sample	from baseline to 6 months
Secondary	Change in Casual Proteinuria	Change of protein concentration in morning urine sample	from baseline to 12 months
Secondary	Change in Specific Gravity of Urine	Change of specific gravity of morning urine sample	from baseline to 1 week
Secondary	Change in Specific Gravity of Urine	Change of specific gravity of morning urine sample	from baseline to 6 months
Secondary	Change in Specific Gravity of Urine	Change of specific gravity of morning urine sample	from baseline to 12 months
Secondary	Change in Renal Resistive Index Measured by Doppler Flowmetry in Left Main Renal Artery	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	from baseline to 6 months
Secondary	Change in Renal Resistive Index Measured by Doppler Flowmetry in Right Main Renal Artery	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	from baseline to 6 months
Secondary	Change in Resistive Index Measured by Renal Doppler Flowmetry in Left Main Renal Artery	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	from baseline to 12 months
Secondary	Change in Resistive Index Measured by Renal Doppler Flowmetry in Right Main Renal Artery	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	from baseline to 12 months
Secondary	Change in Ultrasound Intima Media Thickness of Carotid Artery		from baseline to 6 months
Secondary	Change in Ultrasound Intima Media Thickness of Carotid Artery		from baseline to 12 months
Secondary	Change in Arterial Stiffness	Change of cardio-ankle vascular index(CAVI) assessed by vascular screening device VaSera VS1000 (name of the model)	from baseline to 12 months
Secondary	Change in Arterial Stiffness	Change of cardio-ankle vascular index(CAVI) assessed by vascular screening device VaSera VS1000	from baseline to 6 months
Secondary	Change in Morning Surge of BP		from baseline to 12 months
Secondary	Change in Morning Surge of BP		from baseline to 6 months