NCT01656096
Completed
Phase 4
Renal Sympathetic Denervation in Patients With Mild Refractory Hypertension
University of Leipzig1 site in 1 country71 target enrollmentJuly 2012
ConditionsRefractory Hypertension
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
Investigators
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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