Refractory Hypertension
Conditions
Brief summary
The purpose of this study is to examine the benefit of renal sympathetic denervation in patients with mild refractory hypertension
Interventions
DEVICERenal sympathetic denervation (Symplicity ablation catheter, Medtronic Inc. Minneapolis, Minnesota, USA)
OTHERSham procedure
Sponsors
University of Leipzig
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in systolic blood pressure (ABPM mean value) | 6 months |
Countries
Germany
Outcome results
None listed