Overview

This trial is active, not recruiting.

Condition hypertension, resistant to conventional therapy
Treatments distal renal denervation, conventional renal denervation
Phase phase 1/phase 2
Sponsor Federal State Budgetary Scientific Institution, Research Institute of Cardiology
Start date January 2013
End date July 2016
Trial size 55 participants
Trial identifier NCT02667912, 022

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Endovascular radiofrequency ablation of renal nerves in 6-8 separate points located in segmental branches and distal part of the main trunk of renal artery
distal renal denervation
Percutaneous endovascular intervention when catheter-based electrode is used for stepwise radiofrequency energy delivery to inner surface of segmental branches renal artery in a number of points equally distributed along the length and circumference of the vessels in order to ablate renal plexus accompanying the artery in its course from aorta to the kidney
(Active Comparator)
Endovascular radiofrequency ablation of renal nerves in 6-8 separate points equally distributed within the main trunk of renal artery
conventional renal denervation
Percutaneous endovascular intervention when catheter-based electrode is used for stepwise radiofrequency energy delivery to inner surface of the main trunk of renal artery in a number of points equally distributed along its length and circumference in order to ablate renal plexus accompanying the artery in its course from aorta to the kidney

Primary Outcomes

Measure
Between-group difference in the changes of 24h-mean systolic BP assessed by ambulatory blood pressure monitoring (ABPM)
time frame: From baseline to 6 months

Secondary Outcomes

Measure
Between-group difference in the number of adverse events
time frame: From baseline to 6 months
Between-group difference in the number of adverse events
time frame: From baseline to 12 months
Between-group difference in the changes of arterial resistance index measured by Doppler flowmetry
time frame: From baseline to 6 months
Between-group difference in the changes of arterial resistance index measured by Doppler flowmetry
time frame: From baseline to 12 months
Between-group difference in the changes of serum creatinine
time frame: From baseline to 6 months
Between-group difference in the changes of serum creatinine
time frame: From baseline to 12 months
Between-group difference in the changes of estimated glomerular filtration rate (eGFR)
time frame: From baseline to 6 months
Between-group difference in the changes of eGFR
time frame: From baseline to 12 months
Between-group difference in the changes of 24h-mean diastolic BP
time frame: From baseline to 6 months
Between-group difference in the changes of 24h-mean systolic BP
time frame: From baseline to 12 months
Between-group difference in the changes of 24h-mean diastolic BP
time frame: From baseline to 12 months
Between-group difference in the changes of office systolic BP
time frame: From baseline to 6 months
Between-group difference in the changes of office systolic BP
time frame: From baseline to 12 months
Between-group difference in the changes of office diastolic BP
time frame: From baseline to 6 months
Between-group difference in the changes of office diastolic BP
time frame: From baseline to 12 months
Between-group difference in the changes of daytime systolic BP
time frame: From baseline to 6 months
Between-group difference in the changes of daytime systolic BP
time frame: From baseline to 12 months
Between-group difference in the changes of daytime diastolic BP
time frame: From baseline to 6 months
Between-group difference in the changes of daytime diastolic BP
time frame: From baseline to 12 months
Between-group difference in the changes of nighttime systolic BP
time frame: From baseline to 6 months
Between-group difference in the changes of nighttime systolic BP
time frame: From baseline to 12 months
Between-group difference in the changes of nighttime diastolic BP
time frame: From baseline to 6 months
Between-group difference in the changes of nighttime diastolic BP
time frame: From baseline to 12 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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, - 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)

Additional Information

Official title Anatomically Optimized Distal Renal Denervation for Treatment of Resistant Hypertension
Principal investigator Stanislav Pekarskiy, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Federal State Budgetary Scientific Institution, Research Institute of Cardiology.