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Clinical Trials/NCT00888433
NCT00888433
Completed
Not Applicable

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

Medtronic Vascular20 sites in 10 countries106 target enrollmentJune 2009
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ConditionsUncontrolled Hypertension

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Uncontrolled Hypertension
Sponsor
Medtronic Vascular
Enrollment
106
Locations
20
Primary Endpoint
Office Systolic Blood Pressure Reduction
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
June 2009
End Date
May 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Medtronic Vascular
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Office Systolic Blood Pressure Reduction

Time Frame: Baseline to 6 months

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

Study Sites (20)

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