Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Medtronic Vascular

ClinicalTrials.gov Identifier:

NCT00888433

First received: April 24, 2009

Last updated: October 30, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 24, 2009

Last Updated Date

October 30, 2012

Start Date ^ICMJE

June 2009

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Blood Pressure Reduction [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00888433 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

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-2)

Official Title ^ICMJE

Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)

Brief Summary

An international, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation in patients with uncontrolled hypertension.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Uncontrolled Hypertension

Intervention ^ICMJE

Device: Renal Denervation (Symplicity® Catheter System)

Catheter-based renal denervation

Study Arm (s)

Experimental: Renal Denervation
Renal Denervation and maintenance of anti-hypertensive medications

Intervention: Device: Renal Denervation (Symplicity® Catheter System)
No Intervention: Maintenance of Medications
Maintenance of anti-hypertensive medications

Publications *

* 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

Enrollment ^ICMJE

106

Estimated Completion Date

December 2015

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

systolic blood pressure >=160mmHg (>=150 mmHg for type 2 diabetics);
on 3 or more antihypertensive medications
>= 18 and =< 85 years of age.

Exclusion Criteria:

renal artery abnormalities
eGFR < 45mL/min
MI, angina, CVA within 6 months
Type 1 diabetes
ICD or pacemaker, or any other metallic implant not compatible with MRI
others

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia, Austria, Belgium, France, Germany, Latvia, Poland, Spain, Switzerland, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00888433

Other Study ID Numbers ^ICMJE

TP-058

Has Data Monitoring Committee

Yes

Responsible Party

Medtronic Vascular

Study Sponsor ^ICMJE

Medtronic Vascular

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Murray Esler, MBBS

The Baker IDI Heart & Diabetes Institute

Information Provided By

Medtronic Vascular

Verification Date

October 2012

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

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