NCT02608632

Brief Summary

To increase the number of responders using HFS-guided renal artery denervation (RDN) in patients with resistant and moderate resistant hypertension

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P50-P75 for phase_2 hypertension

Timeline
Completed

Started Feb 2013

Typical duration for phase_2 hypertension

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

November 20, 2015

Status Verified

November 1, 2015

Enrollment Period

2.8 years

First QC Date

November 17, 2015

Last Update Submit

November 19, 2015

Conditions

Hypertension

Keywords

Renal denervationAblation

Outcome Measures

Primary Outcomes (1)

  • number of responders to renal denervation procedure

    12 month

Secondary Outcomes (2)

  • complications rate

    12 month

  • cross-over rate

    12 month

Study Arms (2)

Group 1 (RDN guided by HFS)

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.

Device: Renal denervation guided by HFS

Group 2 (RDN as standard procedure)

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

Device: Renal denervation as standard procedure

Interventions

Renal denervation guided by HFSDEVICE
Group 1 (RDN guided by HFS)
Renal denervation as standard procedureDEVICE
Group 2 (RDN as standard procedure)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Federal Center of Cardiovascular surgery

Krasnoyarsk, Russia

Location

Regional Hospital

Krasnoyarsk, Russia

Location

Federal Center of Prophylactic Medicine

Moscow, Russia

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2015

First Posted

November 20, 2015

Study Start

February 1, 2013

Primary Completion

December 1, 2015

Study Completion

February 1, 2016

Last Updated

November 20, 2015

Record last verified: 2015-11

Locations

RU(3)