Trial record 1 of 1 for: Symplicity HTN-3: Renal Denervation in Patients With Uncontrolled Hypertension

Previous Study | Return to List | Next Study

Renal Denervation in Patients With Uncontrolled Hypertension (SYMPLICITY HTN-3)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Medtronic Vascular

ClinicalTrials.gov Identifier:

NCT01418261

First received: August 15, 2011

Last updated: May 29, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 15, 2011

Last Updated Date

May 29, 2013

Start Date ^ICMJE

September 2011

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in Office Systolic Blood Pressure [ Time Frame: Baseline to 6 months post-randomization ] [ Designated as safety issue: No ]
Primary Effectiveness Outcome Measure
Incidence of Major Adverse Events through 1 month post-randomization (Renal artery stenosis measured at 6 months) [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01418261 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in average 24-hour Systolic Blood Pressure by ambulatory blood pressure monitoring [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Renal Denervation in Patients With Uncontrolled Hypertension (SYMPLICITY HTN-3)

Official Title ^ICMJE

Not Provided

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Uncontrolled Hypertension

Intervention ^ICMJE

Device: Renal denervation (Symplicity Catheter System)

Symplicity Catheter System

Study Arm (s)

Experimental: Renal Denervation
Subjects are treated with the renal denervation procedure after randomization and are maintained on baseline anti-hypertensive medications

Intervention: Device: Renal denervation (Symplicity Catheter System)
No Intervention: Control group
Subjects are maintained on baseline anti-hypertensive medications

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

530

Completion Date

Not Provided

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01418261

Other Study ID Numbers ^ICMJE

IP125

Has Data Monitoring Committee

Yes

Responsible Party

Medtronic Vascular

Study Sponsor ^ICMJE

Medtronic Vascular

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	George Bakris, MD	Professor of Medicine, Hypertension Center Director University of Chicago Medical Center
Principal Investigator:	Deepak L Bhatt, MD, MPH	VA Boston Healthcare System Department of Cardiology

Information Provided By

Medtronic Vascular

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top