Distal Renal Denervation

Not Applicable

Completed

Interventions: Procedure: Conventional renal denervation
Procedure: Distal renal denervation

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

Brief Summary: Objective of this study is to evaluate whether a distal mode of endovascular renal denervation with the treatment performed primarily in segmental branches of renal artery is more effective than conventional mode of the intervention with the treatment equally distributed within its main trunk for the treatment of drug-resistant hypertension.

Detailed Description: Recent spectacular failure of renal denervation (RDN) therapy in SymplicityHTN-3 trial in fact might be easily predicted from the very beginning. Conventional RDN done as 4-6 point treatments equally distributed within main trunk of renal artery (RA) may only be effective if renal plexus tightly surrounds the artery throughout its whole course with equal longitudinal and circumferential density of the nerve fibers. While this idea itself is unnaturally idealistic also a number of surgical studies demonstrated that proximally majority of renal nerves go at a distance from RA obliquely to its course and join the artery mainly in its distal part (fan-shaped renal plexus with wide base directed toward aorta and apex converging to renal gate). We developed a distal mode of RDN targeting segmental branches of RA and conducted a single-center double-blind randomized controlled parallel group study to compare its efficacy and safety to those of conventional RDN in patients with drug-resistant hypertension.

Recruitment & Eligibility

Inclusion Criteria

systolic BP is equal or greater than 160 mmHg or diastolic BP is equal or greater than 100 mmHg,
stable (>3 months) treatment with full doses of at least 3 antihypertensive drugs including a diuretic,
given written informed consent

Exclusion Criteria

secondary hypertension
24h-mean systolic BP <135 mmHg,
estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2,
extended disease of renal artery,
any other clinically important disorders/comorbidities significantly increasing risk of endovascular intervention (investigator's assessment)

Arm && Interventions

Group	Intervention	Description
Conventional renal denervation	Conventional renal denervation	Endovascular denervation of main trunk of renal artery
Distal renal denervation	Distal renal denervation	Endovascular denervation of segmental branches of renal artery

Primary Outcome Measures

Name	Time	Method
Changes of 24h-mean Systolic BP Assessed by Ambulatory Blood Pressure Monitoring (ABPM)	From baseline to 6 months

Secondary Outcome Measures

Name	Time	Method
Number of Adverse Events	From baseline to 12 months
Changes of Serum Creatinine	From baseline to 12 months
Changes of 24h-mean Diastolic BP	From baseline to 12 months
Changes of 24h-mean Systolic BP	From baseline to 12 months
Changes of Daytime Systolic BP	From baseline to 6 months
Changes of Daytime Mean Systolic BP	From baseline to 12 months
Changes of Nighttime Mean Diastolic BP	From baseline to 12 months
Changes of Estimated Glomerular Filtration Rate (eGFR)	From baseline to 12 months
Changes of Office Diastolic BP	From baseline to 12 months
Changes of Nighttime Mean Systolic BP	From baseline to 12 months
Changes of Arterial Resistance Index Measured by Doppler Flowmetry in the Right Segmental Renal Arteries	From baseline to 6 months	Resistance index is calculated as the relative difference between a peak systolic and end diastolic blood flow velocities assessed by ultrasound Doppler flowmetry
Changes of Arterial Resistance Index Measured by Doppler Flowmetry in the Left Segmental Renal Arteries	From baseline to 6 months	Resistance index calculated as the relative difference between a peak systolic and end diastolic blood flow velocities assessed by ultrasound Doppler flowmetry
Changes of Office Systolic BP	From baseline to 12 months
Changes of Daytime Mean Diastolic BP	From baseline to 12 months