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Clinical Trials/NCT01656096
NCT01656096
Completed
Phase 4

Renal Sympathetic Denervation in Patients With Mild Refractory Hypertension

University of Leipzig1 site in 1 country71 target enrollmentJuly 2012

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Refractory Hypertension
Sponsor
University of Leipzig
Enrollment
71
Locations
1
Primary Endpoint
Change in systolic blood pressure (ABPM mean value)
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
July 2012
End Date
July 2014
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Leipzig
Responsible Party
Principal Investigator
Principal Investigator

Steffen Desch, MD

Principal Investigator

University of Leipzig

Eligibility 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

Outcomes

Primary Outcomes

Change in systolic blood pressure (ABPM mean value)

Time Frame: 6 months

Study Sites (1)

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