Renal Denervation in Patients With Refractory Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT00753285
First received: September 12, 2008
Last updated: September 15, 2014
Last verified: September 2014
  Purpose

The purpose of this study is to investigate the clinical utility of renal denervation for the treatment of refractory hypertension.


Condition Intervention
Hypertension
Device: Renal Denervation with a catheter-based procedure
Procedure: Denervation Group

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Renal Denervation in Patients With Refractory Hypertension

Resource links provided by NLM:


Further study details as provided by Medtronic Vascular:

Primary Outcome Measures:
  • Safety - complications associated with delivery and/or use of the Ardian Catheter, adverse renal events, electrolyte disturbances, hemodynamic events. [ Time Frame: Through 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Physiologic response to renal denervation (e.g., blood pressure reduction) [ Time Frame: Through 3 years ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: September 2008
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Denervation Group
Denervation Group
Device: Renal Denervation with a catheter-based procedure
Disruption of the renal nerves with a catheter-based procedure.
Procedure: Denervation Group
Single-arm denervation group

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Systolic blood pressure of 160 mmHg or greater
  • On 3 or more antihypertensive medications
  • eGFR >= 45 mL/min

Exclusion Criteria:

  • Renal artery abnormalities
  • Known secondary hypertension attributable to a cause other than sleep apnea
  • MI, angina, CVA within 6 months
  • Type 1 diabetes
  • Others
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00753285

Locations
United States, Illinois
Prairie Heart Institute
Springfield, Illinois, United States, 62701
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
Medtronic Vascular
Investigators
Principal Investigator: Henry Krum, PhD Monash University and the Alfred Hospital
  More Information

Additional Information:
No publications provided by Medtronic Vascular

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT00753285     History of Changes
Other Study ID Numbers: TP-040
Study First Received: September 12, 2008
Last Updated: September 15, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014