Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)
- Conditions
- Uncontrolled Hypertension
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 106
- systolic blood pressure >=160mmHg (>=150 mmHg for type 2 diabetics);
- on 3 or more antihypertensive medications
- >= 18 and =< 85 years of age.
- 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
- 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (20)
Alfred Hospital
🇦🇺Melbourne, Australia
Vienna General Hospital
🇦🇹Vienna, Austria
Cliniques Universitaires Saint Luc
🇧🇪Brussels, Belgium
Hopital Européen Georges Pompidou
🇫🇷Paris, France
Herzzentrum Bad Krozingen
🇩🇪Bad Krozingen, Germany
Universität zu Köln
🇩🇪Cologne, Germany
Universitaetsklinikum Dusseldorf
🇩🇪Dusseldorf, Germany
University of Erlangen at Nuremburg
🇩🇪Erlangen, Germany
Universitaetsklinikum Essen
🇩🇪Essen, Germany
CardioVascular Center Frankfurt
🇩🇪Frankfurt, Germany
Scroll for more (10 remaining)Alfred Hospital🇦🇺Melbourne, Australia