SYMPLICITY HTN-3 Renal Denervation in Patients With Uncontrolled Hypertension

Completed · Not applicable

Conditions studied: Uncontrolled Hypertension

In brief

The Symplicity HTN-3 study is a, multi-center, prospective, single-blind, randomized, controlled study of the safety and effectiveness of renal denervation in subjects with uncontrolled hypertension. Bilateral renal denervation will be performed using the Symplicity Catheter - a percutaneous system that delivers radiofrequency (RF)energy through the luminal surface of the renal artery.

Key facts

Study ID

NCT01418261

Run by

Medtronic Vascular

People needed

535

Starts

2011-09-01

Expected to finish

2017-02-17

Last updated by the study team

2017-04-26

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Individual is ≥ 18 and ≤ 80 years old at time of randomization.
• Individual is receiving a stable medication regimen including full tolerated doses of 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic (with no changes for a minimum of 2 weeks prior to screening) that is expected to be maintained without changes for at least 6 months.
• Individual has an office systolic blood pressure (SBP) of ≥ 160 mmHg based on an average of 3 blood pressure readings measured at both an initial screening visit and a confirmatory screening visit

You may not qualify if…

• Individual has an estimated glomerular filtration rate (eGFR) of < 45 mL/min/1.73 m2
• Individual has an Ambulatory Blood Pressure Monitoring (ABPM) 24 hour average SBP < 135 mmHg
• Individual has type 1 diabetes mellitus
• Individual requires chronic oxygen support or mechanical ventilation (e.g., tracheostomy, CPAP, BiPAP) other than nocturnal respiratory support for sleep apnea.
• Individual has primary pulmonary hypertension.
• Individual is pregnant, nursing or planning to be pregnant.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Scripps Clinic/Scripps Green Hospital — La Jolla, California, United States
• Kaiser Permanente - Los Angeles Medical Center — Los Angeles, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• St. Joseph Hospital — Orange, California, United States
• San Diego Cardiac Center — San Diego, California, United States
• Stanford University — Stanford, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Howard University Hospital — Washington D.C., District of Columbia, United States
• Shands / University of Florida — Gainesville, Florida, United States
• Mayo Clinic — Jacksonville, Florida, United States
• University Of Miami — Miami, Florida, United States
• Baptist Cardiac &Vascular Institute, Baptist Health Systems — Miami, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Emory University Hospital Midtown — Atlanta, Georgia, United States
• Piedmont Heart Institute — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Midwest Heart Foundation — Oakbrook Terrace, Illinois, United States
• Prairie Heart Institute — Springfield, Illinois, United States
• Iowa Heart Center Research — Des Moines, Iowa, United States
• University of Kentucky — Lexington, Kentucky, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• Cardiology, PC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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