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Renal Sympathetic Denervation in Mild Refractory Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Steffen Desch, MD, University of Leipzig
ClinicalTrials.gov Identifier:
NCT01656096
First received: July 31, 2012
Last updated: October 27, 2016
Last verified: October 2016
  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
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: Renal Sympathetic Denervation in Patients With Mild Refractory Hypertension

Further study details as provided by Steffen Desch, MD, University of Leipzig:

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

Enrollment: 71
Study Start Date: July 2012
Study Completion Date: July 2014
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   (Adult, Senior)
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
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

Locations
Germany
University of Leipzig Heart Center
Leipzig, Germany, 04289
Sponsors and Collaborators
University of Leipzig
Investigators
Principal Investigator: Steffen Desch, MD Heartcenter Leipzig GmbH
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: October 27, 2016

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 22, 2017