Renal Sympathetic Denervation and Potential Effects on Glucose Metabolism and Cardiovascular Risk-Factors (Re-Shape)

University Hospital of North Norway

Status: Completed

Conditions: Hypertension, Resistant to Conventional Therapy

Treatments: Procedure: Renal sympathetic denervation

Study type: Interventional

Funder types: Other

Identifiers

NCT01630928

2011/1296 (REK)

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Renal sympathetic denervation

Experimental group

Description:

Patients with treatment resistant hypertension

Treatment:

Procedure: Renal sympathetic denervation