Status:

COMPLETED

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

Lead Sponsor:

Medtronic Vascular

Conditions:

Uncontrolled Hypertension

Eligibility:

All Genders

18-85 years

Phase:

NA

Brief Summary

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

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

June 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2015

Estimated Enrollment :

106 Patients enrolled

Trial Details

Trial ID

NCT00888433

Start Date

June 1 2009

End Date

May 1 2015

Last Update

May 20 2015

Active Locations (20)

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Page 1 of 5 (20 locations)

1

Alfred Hospital

Melbourne, Australia

2

Vienna General Hospital

Vienna, Austria

3

Cliniques Universitaires Saint Luc

Brussels, Belgium

4

Hopital Européen Georges Pompidou

Paris, France