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Renal Sympathectomy in Treatment Resistant Essential Hypertension, a Sham Controlled Randomized Trial

NCT01459900 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2016-09-20

No results posted yet for this study

Summary

The purpose of this double blind, randomized and sham controlled study is to determine whether renal denervation in terms of catheter based ablation in the renal arteries is effective in lowering blood pressure in patients with treatment resistant hypertension. The blood pressure lowering effect will be evaluated by 24 hours ambulatory blood pressure measurement at baseline and after 1, 3 and 6 months of follow up. Secondary end point evaluation concerns hemodynamic measures using echocardiography, applanation tonometry and forearm plethysmography.

Conditions

Interventions

PROCEDURE

Renal artery ablation

Catheter based renal denervation by applying low power radiofrequency to the renal artery using the Ardian Medtronic Simplicity Catheter, introduced by femoral artery access.

PROCEDURE

Renal angiography

Renal angiography by femoral access.

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Regionshospitalet Silkeborg

    collaborator OTHER

  • Randers Regional Hospital

    collaborator OTHER

  • Regional Hospital Holstebro

    collaborator OTHER

  • Central Jutland Regional Hospital

    collaborator OTHER

  • Aarhus University Hospital Skejby

    lead OTHER

Principal Investigators

  • Ole N Mathiassen, MD, PhD · Aarhus University Hospital, Dep. Cardiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01459900 on ClinicalTrials.gov