Renal Sympathetic Denervation in Mild Refractory Hypertension

University of Leipzig

Status and phase: Completed; Phase 4

Conditions: Refractory Hypertension

Treatments: Device: Renal sympathetic denervation (Symplicity ablation catheter, Medtronic Inc. Minneapolis, Minnesota, USA); Other: Sham procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT01656096

RSD-Leipzig

Details and patient eligibility

About

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

Enrollment: 71 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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71 participants in 2 patient groups

Renal sympathetic denervation

Experimental group

Description:

Renal sympathetic denervation (Symplicity ablation catheter, Medtronic Inc. Minneapolis, Minnesota, USA)

Treatment:

Device: Renal sympathetic denervation (Symplicity ablation catheter, Medtronic Inc. Minneapolis, Minnesota, USA)

Sham procedure

Sham Comparator group

Description:

Sham procedure mimicking the renal sympathetic denervation procedure in the experimental arm

Treatment:

Other: Sham procedure