Distal Renal Denervation

Tomsk National Research Medical Center of the Russian Academy of Sciences

Status: Completed

Conditions: Hypertension, Resistant to Conventional Therapy

Treatments: Procedure: Distal renal denervation; Procedure: Conventional renal denervation

Study type: Interventional

Funder types: Other

Identifiers

NCT02667912

022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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55 participants in 2 patient groups

Distal renal denervation

Experimental group

Description:

Endovascular denervation of segmental branches of renal artery

Treatment:

Procedure: Distal renal denervation

Conventional renal denervation

Active Comparator group

Description:

Endovascular denervation of main trunk of renal artery

Treatment:

Procedure: Conventional renal denervation