Distal Renal Denervation

T

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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