Denervation of the REnal Artery in Metabolic Syndrome (DREAMS)

Inclusion Criteria:

• Patients should have a high fasting glucose (fasting serum glucose ≥5.6 mmol/L (≥100 mg/dL)), without the use of antidiabetic drugs at the time of inclusion AND should have a 24 hour ambulatory SBP >130 mmHg, without the use of antihypertensive drugs at the time of inclusion.
• Patients should fulfil one or more other criteria to meet the definition of the metabolic syndrome.
• Individual understands the study procedures, alternative treatments available, risks involved with the study and voluntarily agrees to participate by giving informed consent.
• 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 of inclusion.
• Individual is treated with more than one type of antihypertensive medication at time of inclusion.
• Individual is treated with more than one type of drug for diabetes mellitus 2 at time of 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 a cerebrovascular accident within 6 months of the screening visit, or has widespread atherosclerosis, 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 reduction of BP would be considered hazardous.
• Individual has an implantable cardioverter defibrillator (ICD) or pacemaker whose settings cannot allow for RF energy delivery.
• Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or 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, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply 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 and fludrocortisone)
  • Acenocoumarol or phenprocoumon that cannot be temporarily stopped for the procedure.