Status:
COMPLETED
Denervation of the REnal Artery in Metabolic Syndrome
Lead Sponsor:
UMC Utrecht
Conditions:
Insulin Resistance
Blood Pressure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The current prevalence of hypertension as part of the metabolic syndrome is substantial and is increasing with the rise of obesity worldwide. Chronic elevation of sympathetic nervous system (SNS) acti...
Detailed Description
Objectives: The objectives of this study are: to compare changes in insulin resistance in patients with ORH after RDN; to evaluate the safety of PRDN in this patient group; to compare changes in blood...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01465724
Start Date
November 1 2011
End Date
September 1 2014
Last Update
December 30 2014
Active Locations (1)
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1
UMC Utrecht
Utrecht, Utrecht, Netherlands