Renal Sympathetic Denervation in Metabolic Syndrome (Metabolic Syndrome Study)

Abbott

Status

Completed

Conditions

Metabolic Syndrome

Treatments

Procedure: Renal Denervation

Device: EnligHTN™ Renal Denervation System.

Study type

Interventional

Funder types

Industry

Identifiers

NCT01911078

CI-12-079-EU-RD

Details and patient eligibility

About

The purpose of this clinical investigation is to determine the effects of renal sympathetic denervation on insulin resistance and muscle sympathetic nerve activity in patients with metabolic syndrome.

Enrollment

20 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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