Renal Sympathetic Denervation in Metabolic Syndrome (Metabolic Syndrome Study)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01911078
• Date of registration: 24/07/2013
• Prospective Registration: Yes
• Primary sponsor: Abbott Medical Devices
• Public title: Renal Sympathetic Denervation in Metabolic Syndrome (Metabolic Syndrome Study)
• Scientific title: Renal Sympathetic Denervation in Metabolic Syndrome (Metabolic Syndrome Study)
• Date of first enrolment: September 2014
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01911078
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Greece

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patient with office blood pressure =140/90 mmHg and 24-hour ambulatory blood pressure
=130/80 mmHg at Baseline despite the stable use of at least two anti-hypertensive
drugs at maximum tolerated doses of the patient for at least 4 weeks

- Patient with a fasting glucose =100 mg/dL (=5.6 mmol/L) at Baseline or on drug
treatment for elevated glucose

- Patient with a waist circumference =102 cm (=40 inches) for male or =88 cm (=35
inches) for female at Baseline

- Patient with any of the remaining two metabolic syndrome diagnostic criteria listed as
follows at Baseline

- Triglycerides =150 mg/dL (=1.7 mmol/L) or on drug treatment for elevated
triglycerides

- High density lipid cholesterol (HDL-C) <40 mg/dL (<1.03 mmol/L) for male or <50
mg/dL (<1.30 mmol/L) for female or on drug treatment for reduced HDL-C

- Patient is =18 and =70 years old

- Patient must be able and willing to provide written informed consent to participate in
this clinical investigation

- Patient must be able and willing to comply with the required follow-up schedule

Exclusion Criteria:

- Patient with secondary hypertension

- Patient with type I diabetes mellitus or type II diabetes mellitus requiring insulin
therapy

- Patient with prior renal angioplasty, renal denervation, indwelling renal stents
and/or aortic stent grafts

- Patient with renal arteries <4.0 mm in diameter

- Patient with significant renovascular abnormalities (such as renal artery stenosis
>30%)

- Patient with an estimated glomerular filtration rate (eGFR) of <45 mL/min per 1.73 m2
using the Modified Diet in Renal Disease (MDRD) formula

- Patient with hemodynamically significant valvular heart disease, as determined by
Study Investigator

- Patient has had a myocardial infarction, unstable angina pectoris or cerebrovascular
accident less than 180 days at Baseline or is expected to have cardiovascular
intervention within the next 180 days

- Patient is in chronic atrial fibrillation/flutter or with severe conduction
abnormalities or with an implantable cardioverter defibrillator (ICD) or pacemaker
whose settings cannot allow for radiofrequency (RF) energy delivery

- Patient is currently being treated with drugs that cause salt retention (such as
systemic corticosteroids or fludrocortisone), centrally acting sympatholytic
antihypertensive drugs, direct vasodilators (such as alpha blockers) and continuous
positive airway pressure (CPAP) therapy for obstructive sleep apnea

- Patient with an active systemic infection or blood-clotting abnormalities or allergy
to radiographic contrast

- Patient is pregnant or of childbearing potential and is not using adequate
contraceptive methods or nursing

- Patient is participating in another clinical investigation

- Patient has a life expectancy less than 12 months, as determined by Study Investigator



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Metabolic Syndrome

Intervention(s)

Device: EnligHTN™ Renal Denervation System.

Procedure: Renal Denervation

Primary Outcome(s)

Change in muscle sympathetic nerve activity (MSNA) from baseline to 3 months after renal denervation [Time Frame: Baseline and Month 3]

Change in insulin resistance from baseline to 3 months after renal denervation [Time Frame: Baseline and Month 3]

Secondary Outcome(s)

Change in muscle sympathetic nerve activity (MSNA) from baseline to 12 months after renal denervation [Time Frame: Baseline and Month 12]

Change in insulin resistance from baseline to 12 months after renal denervation [Time Frame: Baseline and Month 12]

Secondary ID(s)

CI-12-079-EU-RD

Source(s) of Monetary Support

Please refer to primary and secondary sponsors