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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT00888433
First received: April 24, 2009
Last updated: May 21, 2014
Last verified: May 2014

April 24, 2009
May 21, 2014
June 2009
September 2010   (final data collection date for primary outcome measure)
Office Systolic Blood Pressure Reduction [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
The primary effectiveness endpoint is change in Office Systolic Blood Pressure (SBP) from baseline to 6 months post-randomization.
Not Provided
Complete list of historical versions of study NCT00888433 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)
Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Uncontrolled Hypertension
Device: Renal Denervation (Symplicity® Renal Denervation System)
Catheter-based renal denervation
  • Experimental: Renal Denervation
    Renal Denervation and maintenance of anti-hypertensive medications
    Intervention: Device: Renal Denervation (Symplicity® Renal Denervation System)
  • No Intervention: Control
    Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
106
December 2015
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Belgium,   France,   Germany,   Latvia,   Poland,   Spain,   Switzerland,   United Kingdom
 
NCT00888433
TP-058
Yes
Medtronic Vascular
Medtronic Vascular
Not Provided
Principal Investigator: Murray Esler, MBBS The Baker IDI Heart & Diabetes Institute
Medtronic Vascular
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP