Renal Denervation in Patients With Refractory Hypertension

Not Applicable

Completed

• Conditions: Hypertension

• Registration Number: NCT00664638
• Lead Sponsor: Medtronic Vascular

Brief Summary

To investigate the clinical utility of renal denervation in the treatment of refractory hypertension.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-21
• Study First Submitted QC: 2008-04-21
• Study First Posted: 2008-04-23
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-01
• Last Update Posted: 2013-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• >= 18 years of age
• a systolic blood pressure of 160mmHg or more
• receiving and adhering to full doses of at least three antihypertensive drugs
• estimated glomerular filtration rate (eGFR) of ≥45mL/min
• agrees to have the study procedure(s) performed and additional procedures and evaluations
• is competent and willing to provide written, informed consent to participate in this clinical study

Exclusion Criteria

• hemodynamically or anatomically significant renal artery stenosis
• has a history or prior renal artery angioplasty
• has experienced MI, unstable angina pectoris, or CVA within 6 months
• has hemodynamically significant valvular heart disease
• has Type 1 diabetes
• has an implantable cardioverter defibrillator (ICD) or pacemaker, or any other metallic implant which is not compatible with magnetic resonance imaging (MRI)
• requires respiratory support
• is pregnant, nursing, or planning to be pregnant
• has known, unresolved history of drug use or alcohol dependency.
• is currently enrolled in another investigational drug or device trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To document that renal denervation achieved via the delivery of RF energy is safe, and not associated with clinically significant adverse events, in patients with refractory hypertension.	3 years

Secondary Outcome Measures

Name	Time	Method
To document the physiologic effects of renal denervation in patients with refractory hypertension.	3 years

Trial Locations

Locations (9)

Herzzentrum Bad Krozingen; 🇩🇪 Bad Krozingen, Germany

Clinical Trial Center North; 🇩🇪 Hamburg, Germany

University of Erlangen at Nuremburg; 🇩🇪 Erlangen, Germany

Universitaetsklinikum Duesseldorf; 🇩🇪 Duesseldorf, Germany

Universitatskliniken des Saarlandes; 🇩🇪 Homburg, Germany

CardioVascular Center Frankfurt, Sankt Katharinen; 🇩🇪 Frankfurt, Germany

St. Elisabeth Hospital; 🇩🇪 Bochum, Germany

Klinikum Coburg; 🇩🇪 Coburg, Germany

University of Leipzig - Herzzentrum; 🇩🇪 Leipzig, Germany