Clinical trial NCT02667912: Distal Renal Denervation
Official title: Anatomically Optimized Distal Renal Denervation for Treatment of Resistant Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension, Resistant to Conventional Therapy
Keywords: Hypertension, Catheter Ablation, Renal Nerves
Lead sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
Sponsor class: OTHER
First posted: 2016-01-29
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Changes of 24h-mean Systolic BP Assessed by Ambulatory Blood Pressure Monitoring (ABPM)
timeFrame: From baseline to 6 months
Secondary outcomes:
measure: Number of Adverse Events
timeFrame: From baseline to 6 months
measure: Number of Adverse Events
timeFrame: From baseline to 12 months
measure: Changes of Arterial Resistance Index Measured by Doppler Flowmetry in the Right Segmental Renal Arteries
timeFrame: From baseline to 6 months
measure: Changes of Arterial Resistance Index Measured by Doppler Flowmetry in the Left Segmental Renal Arteries
timeFrame: From baseline to 6 months
measure: Changes of Serum Creatinine
timeFrame: From baseline to 6 months
measure: Changes of Serum Creatinine
timeFrame: From baseline to 12 months
measure: Changes of Estimated Glomerular Filtration Rate (eGFR)
timeFrame: From baseline to 6 months
measure: Changes of Estimated Glomerular Filtration Rate (eGFR)
timeFrame: From baseline to 12 months
measure: Changes of 24h-mean Diastolic BP
timeFrame: From baseline to 6 months
measure: Changes of 24h-mean Systolic BP
timeFrame: From baseline to 12 months
measure: Changes of 24h-mean Diastolic BP
timeFrame: From baseline to 12 months
measure: Changes of Office Systolic BP
timeFrame: From baseline to 6 months
measure: Changes of Office Systolic BP
timeFrame: From baseline to 12 months
measure: Changes of Office Diastolic BP
timeFrame: From baseline to 6 months
measure: Changes of Office Diastolic BP
timeFrame: From baseline to 12 months
measure: Changes of Daytime Systolic BP
timeFrame: From baseline to 6 months
measure: Changes of Daytime Mean Systolic BP
timeFrame: From baseline to 12 months
measure: Changes of Daytime Mean Diastolic BP
timeFrame: From baseline to 6 months
measure: Changes of Daytime Mean Diastolic BP
timeFrame: From baseline to 12 months
measure: Changes of Nighttime Mean Systolic BP
timeFrame: From baseline to 6 months
measure: Changes of Nighttime Mean Systolic BP
timeFrame: From baseline to 12 months
measure: Changes of Nighttime Mean Diastolic BP
timeFrame: From baseline to 6 months
measure: Changes of Nighttime Mean Diastolic BP
timeFrame: From baseline to 12 months
Other outcomes:
Locations:
city: Tomsk
country: Russian Federation
facility: Tomsk National Research Medical Center of the Russian Academy of Sciences
Study officials:
affiliation: Tomsk National Research Medical Center of the Russian Academy of Sciences
name: Stanislav Pekarskiy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pekarskiy SE, Baev AE, Mordovin VF, Semke GV, Ripp TM, Falkovskaya AU, Lichikaki VA, Sitkova ES, Zubanova IV, Popov SV. Denervation of the distal renal arterial branches vs. conventional main renal artery treatment: a randomized controlled trial for treatment of resistant hypertension. J Hypertens. 2017 Feb;35(2):369-375. doi: 10.1097/HJH.0000000000001160.
citation: Pisano A, Iannone LF, Leo A, Russo E, Coppolino G, Bolignano D. Renal denervation for resistant hypertension. Cochrane Database Syst Rev. 2021 Nov 22;11(11):CD011499. doi: 10.1002/14651858.CD011499.pub3.