Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 9 for:    steffen desch
Previous Study | Return to List | Next Study

Renal Sympathetic Denervation in Mild Refractory Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01656096
Recruitment Status : Completed
First Posted : August 2, 2012
Last Update Posted : October 28, 2016
Sponsor:
Information provided by (Responsible Party):
Steffen Desch, MD, University of Leipzig

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to examine the benefit of renal sympathetic denervation in patients with mild refractory hypertension

Condition or disease Intervention/treatment Phase
Refractory Hypertension Device: Renal sympathetic denervation (Symplicity ablation catheter, Medtronic Inc. Minneapolis, Minnesota, USA) Other: Sham procedure Phase 4

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Renal Sympathetic Denervation in Patients With Mild Refractory Hypertension
Study Start Date : July 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Renal sympathetic denervation
Renal sympathetic denervation (Symplicity ablation catheter, Medtronic Inc. Minneapolis, Minnesota, USA)
 Device: Renal sympathetic denervation (Symplicity ablation catheter, Medtronic Inc. Minneapolis, Minnesota, USA)
Sham Comparator: Sham procedure
Sham procedure mimicking the renal sympathetic denervation procedure in the experimental arm
 Other: Sham procedure


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in systolic blood pressure (ABPM mean value) [ Time Frame: 6 months ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Refractory hypertension: 3 or more antihypertensive agents of different classes (including a diuretic) at optimal dosage without change in the 4 weeks preceding randomization
  • Systolic blood pressure of 135-149 and/or diastolic blood pressure of 90-94 mmHg (ABPM mean daytime values)
  • No change in blood pressure medication within 6 months after randomization
  • Age 18 to 75 years
  • Informed consent

Exclusion Criteria:

  • Blood pressure outside range mentioned above
  • Renal, aortic or pelvic anatomy unsuited for renal sympathetic denervation
  • Estimated glomerular filtration rate <45 mL/min/1.73 m² (modification of diet in renal disease formula)
  • Unstable angina pectoris
  • Myocardial infarction within 6 months prior to randomization
  • Planned surgery or cardiovascular intervention within 6 months after randomization
  • Severe heart valve disease
  • Severe comorbidities with limited life expectancy
  • Pregnancy
  • Participation in another trial
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01656096


Locations
Layout table for location information
Germany
University of Leipzig Heart Center
Leipzig, Germany, 04289
Sponsors and Collaborators
University of Leipzig
Investigators
Layout table for investigator information
Principal Investigator: Steffen Desch, MD Heart Center Leipzig - University Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Steffen Desch, MD, Principal Investigator, University of Leipzig
ClinicalTrials.gov Identifier: NCT01656096    
Other Study ID Numbers: RSD-Leipzig
First Posted: August 2, 2012    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases