Overview

This trial is active, not recruiting.

Condition hypertension
Treatments renal denervation guided by hfs, renal denervation as standard procedure
Phase phase 2
Sponsor Meshalkin Research Institute of Pathology of Circulation
Start date February 2013
End date December 2015
Trial size 170 participants
Trial identifier NCT02608632, 7452RDNHFS

Summary

To increase the number of responders using HFS-guided renal artery denervation (RDN) in patients with resistant and moderate 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, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Renal arteries were assessed for suitability of ablation by renal angiography. The real-time 3-dimensional aorta-renal artery maps were reconstructed with the use of navigation system and ablation catheter via femoral artery access. After that high-frequency stimulation (HFS) was used before the initial and after each radiofrequency (RF) delivery within the renal artery. RDN was considered to have been achieved when the sudden increase of blood pressure (> 15 mm Hg from invasive arterial monitoring) was eliminated in response to HFS. RF ablations of 8-12 watts (impedance drop >10%) were applied discretely from the first distal main renal artery bifurcation all the way back to the ostium. The duration of each RF delivery was 60-120 sec, and up to 6 lesions (separated by > 5 mm) were performed both longitudinally and rotationally within each renal artery.
renal denervation guided by hfs
(Active Comparator)
Renal arteries were assessed for suitability of ablation by renal angiography. The real-time 3-dimensional aorta-renal artery maps were reconstructed with the use of navigation system and ablation catheter via femoral artery access. RF ablations of 8-12 watts (impedance drop >10%) were applied discretely from the first distal main renal artery bifurcation all the way back to the ostium. The duration of each RF delivery was 60-120 sec, and up to 6 lesions (separated by > 5 mm) were performed both longitudinally and rotationally within each renal artery. High-frequency stimulation (HFS) was performed before and after RDN to just to verify the response of BP
renal denervation as standard procedure

Primary Outcomes

Measure
number of responders to renal denervation procedure
time frame: 12 month

Secondary Outcomes

Measure
complications rate
time frame: 12 month
cross-over rate
time frame: 12 month

Eligibility Criteria

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

Inclusion Criteria: - Office-based systolic blood pressure of ≥140/90 mm Hg and <160/100 mm Hg (moderate resistant hypertension) or ≥160/100 mm Hg (severe resistant hypertension), despite treatment with 3 antihypertensive drugs (including a diuretic). - A glomerular filtration rate ≥45 mL/min/1⋅73 m2, with modification of diet using a renal disease formula. Exclusion Criteria: - Secondary causes of hypertension - Severe renal artery stenosis or dual renal arteries - Congestive heart failure - Left ventricular ejection fraction <35% - Previous renal artery stenting or angioplasty - Type 1 diabetes mellitus

Additional Information

Official title High Frequency Guided Renal Artery Denervation for Improving Outcome of Renal Ablation Procedure
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Meshalkin Research Institute of Pathology of Circulation.