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

NCT01630928 | Completed DMC

• 1 other identifier: 2011/1296 (REK)
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Renal denervation; Resistant Hypertension; Cardiovascular disease; Diabetes; Quality of LIfe

Outcome Measures

Primary Outcomes (2)

• Change in blood pressure

  Change in blood pressure from baseline to six months after the intervention

  from baseline to six months

• Change in blood pressure

  Change in blood pressure from baseline to two years after the intervention

  from baseline to two years

Secondary Outcomes (14)

• Change in quality of Life

  From baseline to six months

• Changes in glucose production and insulin sensitivity

  from baseline to six months

• Change in quality of Life

  From baseline to two years

• Changes in glucose production and insulin sensitivity

  from baseline to two years

• Effect of RDN on subclinical organ injury: Myocardium

  from baseline to six months

Study Arms (1)

Renal sympathetic denervation

EXPERIMENTAL

Patients with treatment resistant hypertension

Procedure: Renal sympathetic denervation

Interventions

Renal sympathetic denervation PROCEDURE

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.

Also known as: Symplicity Catheter (Medtronic)

Renal sympathetic denervation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 Years.
• Resistant hypertension, as defined in the 2007 ESH-ESC guidelines and confirmed by ambulatory or home blood pressure measurements. (Here office BP \> 140/90 mmHg on 4 or more antihypertensive drugs in adequate dosages (including one diuretic) or certified drug intolerance).
• No known secondary reason for hypertension
• Negative pregnancy test (preferably blood hCG) for female patients of childbearing potential
• Estimated GFR (glomerular filtration rate) \> 45 mL/min/1.73m².
• Willing and able to comply with follow-up requirements
• Signed informed consent

You may not qualify if:

• Type 1 and type 2 diabetes
• Pregnancy
• Allergy to the contrast medium used during RDN and Iohexol clearance.
• Age \> 68 years
• Hemodynamically significant heart valve disease
• Pacemaker or ICD
• Medication that may interfere with the procedure (Anticoagulation, Platelet inhibitors, Steroids), if they cannot be temporarily reduced or stopped.
• Cancer
• Patients with transplanted kidneys
• Reno vascular conditions like diameter \< 4mm, renal artery stenosis or significant atherosclerosis, previous renal artery stenting

Sponsors & Collaborators

• University Hospital of North Norway: lead
• University of Tromso: collaborator
• The Royal Norwegian Ministry of Health: collaborator
• Odd Berg Medical research Foundation: collaborator

Study Sites (1)

University Hospital of North Norway

Tromsø, N-9038, Norway

Location

Related Publications (2)

• Hanssen TA, Subbotina A, Miroslawska A, Solbu MD, Steigen TK. Quality of life following renal sympathetic denervation in treatment-resistant hypertensive patients: a two-year follow-up study. Scand Cardiovasc J. 2022 Dec;56(1):174-179. doi: 10.1080/14017431.2022.2084562.

  PMID: 35686551 DERIVED

• Miroslawska AK, Gjessing PF, Solbu MD, Fuskevag OM, Jenssen TG, Steigen TK. Renal Denervation for Resistant Hypertension Fails to Improve Insulin Resistance as Assessed by Hyperinsulinemic-Euglycemic Step Clamp. Diabetes. 2016 Aug;65(8):2164-8. doi: 10.2337/db16-0205. Epub 2016 May 31.

  PMID: 27246911 DERIVED

MeSH Terms

Conditions

Hypertension Resistant to Conventional Therapy; Cardiovascular Diseases; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Terje K. Steigen, MD, PhD

  Dept. of Cardiology, University Hospital of North Norway and University of Tromsø, Norway

  PRINCIPAL INVESTIGATOR

• Ingrid Toft, MD, PhD

  Dept. of Nephrology, University Hospital of North Norway and University of Tromsø

  STUDY CHAIR

• Marit D Solbu, MD, PhD

  Dept of Nephrology, University Hospital of North Norway and University of Tromsø

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2012
• First Posted: June 28, 2012
• Study Start: March 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 16, 2016

Record last verified: 2016-05

Locations

NO (1)