Denervation of the REnal Artery in Metabolic Syndrome

Inclusion Criteria:

• Patients should have a high fasting glucose (fasting serum glucose ≥5.6 mmol/L (≥100mg/dL)), without the use of antidiabetic drugs at the time of inclusion AND shouldhave a 24 hour ambulatory SBP >130 mmHg, without the use of antihypertensive drugs atthe time of inclusion.

• Patients should fulfil one or more other criteria to meet the definition of themetabolic syndrome.

• Individual understands the study procedures, alternative treatments available, risksinvolved with the study and voluntarily agrees to participate by giving informedconsent.

• Individual is over 18 years of age on the day of signing informed consent.

Exclusion Criteria:

• SBP >180 mmHg and/or DBP >110 mmHg during one or more screening measurements.

• 24-hour ambulatory SBP >170 mmHg and/or 24-hour ambulatory DBP >100 mmHg at time ofinclusion.

• Individual is treated with more than one type of antihypertensive medication at timeof inclusion.

• Individual is treated with more than one type of drug for diabetes mellitus 2 at timeof inclusion and/or the medication for DM type 2 can not be stopped.

• Individual has a treatable secondary cause of hypertension.

• Individual has renal artery anatomy that is ineligible for treatment.

• Individual has an estimated glomerular filtration rate (eGFR) of <45mL/min/1.73m2,using the MDRD calculation.

• Individual has type 1 diabetes mellitus.

• Individual has experienced a myocardial infarction, unstable angina pectoris, or acerebrovascular accident within 6 months of the screening visit, or has widespreadatherosclerosis, with documented intravascular thrombosis or unstable plaques.

• Individual has scheduled or planned surgery or cardiovascular intervention in the next 6 months.

• Individual has hemodynamically significant valvular heart disease for which reductionof BP would be considered hazardous.

• Individual has an implantable cardioverter defibrillator (ICD) or pacemaker whosesettings cannot allow for RF energy delivery.

• Individual has any serious medical condition, which in the opinion of theinvestigator, may adversely affect the safety and/or effectiveness of the participantor the study (i.e., patients with clinically significant peripheral vascular disease,abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, haemophilia,or significant anaemia).

• Individual is pregnant, nursing or planning to be pregnant.

• Individual has a known, unresolved history of drug use or alcohol dependency, lacksthe ability to comprehend or follow instructions, or would be unlikely or unable tocomply with study follow-up requirements.

• Individual is currently enrolled in another investigational drug or device trial.

• Individual is currently being treated with any of the following medications:

• Drugs that cause salt retention (e.g., systemic corticosteroids andfludrocortisone)

• Acenocoumarol or phenprocoumon that cannot be temporarily stopped for theprocedure.