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

Not Applicable

Completed

• Conditions: Uncontrolled Hypertension
• Interventions: Device: Renal Denervation (Symplicity® Renal Denervation System)

• Registration Number: NCT00888433
• Lead Sponsor: Medtronic Vascular

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 available

Study Timeline

• Study First Submitted: 2009-04-24
• Study First Submitted QC: 2009-04-24
• Study First Posted: 2009-04-27
• Study Start: 2009-06
• Primary Completion: 2010-09
• Results First Submitted: 2013-09-13
• Results First Submitted QC: 2014-01-10
• Results First Posted: 2014-02-24
• Status Verified: 2015-05
• Study Completion: 2015-05
• Last Update Submitted: 2015-05-04
• Last Update Posted: 2015-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Renal Denervation	Renal Denervation (Symplicity® Renal Denervation System)	Renal Denervation and maintenance of anti-hypertensive medications

Primary Outcome Measures

Name	Time	Method
Office Systolic Blood Pressure Reduction	Baseline to 6 months	The primary effectiveness endpoint is change in Office Systolic Blood Pressure (SBP) from baseline to 6 months post-randomization.

Trial Locations

Locations (20)

Herzzentrum Bad Krozingen; 🇩🇪 Bad Krozingen, Germany

Universitatskliniken des Saarlandes; 🇩🇪 Homburg, Germany

University of Leipzig - Herzzentrum; 🇩🇪 Leipzig, Germany

Universitatsklinikum Schleswig-Holstein, Luebeck Campus; 🇩🇪 Leubeck, Germany

Vienna General Hospital; 🇦🇹 Vienna, Austria

Cliniques Universitaires Saint Luc; 🇧🇪 Brussels, Belgium

University of Glasgow; 🇬🇧 Glasgow, United Kingdom

Barts and the London School of Dentistry & Medicine; 🇬🇧 London, United Kingdom

Universität zu Köln; 🇩🇪 Cologne, Germany

Hospital 12 de Octubre; 🇪🇸 Madrid, Spain

Samodzielna Pracownia Hemodynamiczna; 🇵🇱 Warsaw, Poland

Kent and Canterbury Hospital; 🇬🇧 Canterbury, United Kingdom

University of Erlangen at Nuremburg; 🇩🇪 Erlangen, Germany

Alfred Hospital; 🇦🇺 Melbourne, Australia

Hopital Européen Georges Pompidou; 🇫🇷 Paris, France

Universitaatsspital Zurich; 🇨🇭 Zurich, Switzerland

Universitaetsklinikum Dusseldorf; 🇩🇪 Dusseldorf, Germany

CardioVascular Center Frankfurt; 🇩🇪 Frankfurt, Germany

Pauls Stradins Clinical University Hospital; 🇱🇻 Riga, Latvia

Universitaetsklinikum Essen; 🇩🇪 Essen, Germany