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Renal Sympathetic Denervation in Mild Refractory Hypertension

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of Leipzig
Sponsor:
Information provided by (Responsible Party):
Steffen Desch, MD, University of Leipzig
ClinicalTrials.gov Identifier:
NCT01656096
First received: July 31, 2012
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to examine the benefit of renal sympathetic denervation in patients with mild refractory hypertension


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Renal Sympathetic Denervation in Patients With Mild Refractory Hypertension

Resource links provided by NLM:


Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • Change in systolic blood pressure (ABPM mean value) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: July 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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: NCT01656096

Contacts
Contact: Steffen Desch, MD 0049341865 ext 0 stdesch@web.de

Locations
Germany
University of Leipzig Heart Center Recruiting
Leipzig, Germany, 04289
Contact: Steffen Desch, MD    0049341865 ext 0    stdesch@web.de   
Sponsors and Collaborators
University of Leipzig
Investigators
Principal Investigator: Steffen Desch, MD University of Leipzig
  More Information

No publications provided

Responsible Party: Steffen Desch, MD, Principal Investigator, University of Leipzig
ClinicalTrials.gov Identifier: NCT01656096     History of Changes
Other Study ID Numbers: RSD-Leipzig
Study First Received: July 31, 2012
Last Updated: August 5, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 23, 2014