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Denervation of the REnal Artery in Metabolic Syndrome

NCT01465724 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2014-12-30

No results posted yet for this study

Summary

The current prevalence of hypertension as part of the metabolic syndrome is substantial and is increasing with the rise of obesity worldwide. Chronic elevation of sympathetic nervous system (SNS) activity has been identified as a common and key factor in disease states as obesity-related hypertension (ORH). The renal sympathetic nerves are a major contributor to the complex pathophysiology of this elevated SNS activity. Percutaneous renal denervation (PRDN), the deliberate disruption of the nerves connecting the kidneys with the central nervous system, has been shown to be an effective means of modulating elevated SNS activity.

This current study is an observational feasibility study, with the aim to investigate the effect of renal denervation on changes in insulin resistance and blood pressure in patients with obesity related hypertension. The investigators will study different variables: a laboratorial set, a set of blood pressure measurements and a set of investigations in the vascular laboratory.

Hypothesis

* The investigators hypothesize that renal denervation has a beneficial effect on insulin resistance.
* The investigators hypothesize that there will be no complications related to the device or procedure.

Conditions

Interventions

PROCEDURE

Renal denervation

percutaneous selective renal sympathetic denervation with the use of the Symplicity Catheter system.

Sponsors & Collaborators

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Michiel Voskuil, MD, PhD · UMC Utrecht

  • Willemien Verloop, MD · UMC Utrecht

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • Netherlands

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 NCT01465724 on ClinicalTrials.gov