SYMPLICITY HTN-3 Renal Denervation in Patients With Uncontrolled Hypertension

Not Applicable

Completed

• Conditions: Uncontrolled Hypertension

• Registration Number: NCT01418261
• Lead Sponsor: Medtronic Vascular

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2011-08-15
• Study First Submitted QC: 2011-08-16
• Study First Posted: 2011-08-17
• Study Start: 2011-09
• Primary Completion: 2013-12
• Disposition First Submitted: 2014-10-03
• Disposition First Submitted QC: 2014-10-03
• Disposition First Posted: 2014-10-13
• Study Completion: 2017-02-17
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 535

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Office Systolic Blood Pressure	Baseline to 6 months post-randomization	Primary Effectiveness Outcome Measure

Secondary Outcome Measures

Name	Time	Method
Change in average 24-hour Systolic Blood Pressure by ambulatory blood pressure monitoring	Baseline to 6 months

Trial Locations

Locations (79)

Cardiology, PC; 🇺🇸 Birmingham, Alabama, United States

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

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