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

NCT ID: NCT01630928

Last Updated: 2016-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2015-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Renal sympathetic denervation

Patients with treatment resistant hypertension

Group Type: EXPERIMENTAL

Renal sympathetic denervation

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

Symplicity Catheter (Medtronic)

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Tromso

OTHER

Sponsor Role: collaborator

The Royal Norwegian Ministry of Health

OTHER

Sponsor Role: collaborator

Odd Berg Medical research Foundation

UNKNOWN

Sponsor Role: collaborator

University Hospital of North Norway

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Terje K. Steigen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Ingrid Toft, MD, PhD

Role: STUDY_CHAIR

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

Marit D Solbu, MD, PhD

Role: STUDY_DIRECTOR

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

Locations

University Hospital of North Norway

Tromsø, , Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 35686551 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27246911 (View on PubMed)

Other Identifiers

2011/1296 (REK)

Identifier Type: -

Identifier Source: org_study_id