Renal Sympathetic Denervation in Mild Refractory Hypertension

This study is currently recruiting participants.
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
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
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 22, 2014