Distal Renal Denervation

Tomsk National Research Medical Center of the Russian Academy of Sciences55 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Hypertension, Resistant to Conventional Therapy

Interventions

Distal renal denervationPROCEDURE

Percutaneous endovascular intervention when catheter-based electrode (Symplicity Flex; Medtronic, Inc.) is used for stepwise radiofrequency energy delivery to segmental branches of the renal artery in a number of points distributed along the length and circumference of the vessels in order to ablate renal nerve plexus

Conventional renal denervationPROCEDURE

Percutaneous endovascular intervention when catheter-based electrode (Symplicity Flex; Medtronic, Inc.) is used for stepwise radiofrequency energy delivery to the main trunk of the renal artery in a number of points equally distributed along its length and circumference in order to ablate renal nerve plexus

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Locations (1)

Tomsk National Research Medical Center of the Russian Academy of Sciences

Tomsk, Russia