Renal Sympathetic Denervation and Potential Effects on Glucose Metabolism and Cardiovascular Risk-Factors

Summary

The Re-Shape CV-Risk Study is a clinical study where renal adrenergic denervation (RDN) is done in high risk patients with treatment-resistant hypertension. RDN is a mini-invasive, percutaneous technique where an ablation catheter is inserted through a femoral artery into the renal arteries, for destruction of the adrenergic nerve bundles in the artery adventitia by means of radio-frequency ablation. RDN leads to sympathetic denervation of the kidneys, which in the "Symplicity trials" led to an impressive reduction of blood pressure (- 33 /-11 mmHg). In a pilot study, where 40 % of the patients had diabetes, RDN seemed to have beneficial effects not only on blood pressure, but also on insulin sensitivity and hyperinsulinaemia.

The investigators aim to introduce RDN as a clinical study where blood pressure reduction and methodical, technical aspects will be evaluated, but more importantly, also additional effects of RDN on sub-clinical organ damage (endothelial function, vascular stiffness, fundus-, heart-, kidney injury), quality of life, arrhythmia, and glucose metabolism. The investigators hypothesis is that RDN will have positive effect on glucose metabolism, QOL and sub-clinical organ damage.

Conditions

• Hypertension, Resistant to Conventional Therapy

Interventions

PROCEDURE

Renal sympathetic denervation

This is a mini-invasive trans-catheter procedure with access via a 6F introducer in one of the femoral arteries. The renal sympathetic nerves arise from T10-L2, arborize around the renal artery and primarily lie within the adventitia. A specialized radiofrequency (RF) ablation catheter is introduced into the renal arteries, first one side, then on the other. Usually, 4-6 two-minute treatments per artery using a proprietary RF generator with automated low power and built-in safety algorithms are sufficient to ablate the sympathetic afferent and efferent fibers.

Sponsors & Collaborators

• University of Tromso

  collaborator OTHER

• The Royal Norwegian Ministry of Health

  collaborator OTHER

• Odd Berg Medical research Foundation

  collaborator UNKNOWN

• University Hospital of North Norway

  lead OTHER

Principal Investigators

• Terje K. Steigen, MD, PhD · Dept. of Cardiology, University Hospital of North Norway and University of Tromsø, Norway

• Ingrid Toft, MD, PhD · Dept. of Nephrology, University Hospital of North Norway and University of Tromsø

• Marit D Solbu, MD, PhD · Dept of Nephrology, University Hospital of North Norway and University of Tromsø

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-03-31

Primary Completion

2015-12-31

Completion

2015-12-31

Countries

• Norway

Study Locations