Renal Sympathetic Denervation in Mild Refractory Hypertension

Phase 4

Completed

• Conditions: Refractory Hypertension
• Interventions: Other: Sham procedure; Device: Renal sympathetic denervation (Symplicity ablation catheter, Medtronic Inc. Minneapolis, Minnesota, USA)

• Registration Number: NCT01656096
• Lead Sponsor: University of Leipzig

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-31
• Study First Submitted QC: 2012-07-31
• Study First Posted: 2012-08-02
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham procedure	Sham procedure	Sham procedure mimicking the renal sympathetic denervation procedure in the experimental arm
Renal sympathetic denervation	Renal sympathetic denervation (Symplicity ablation catheter, Medtronic Inc. Minneapolis, Minnesota, USA)	Renal sympathetic denervation (Symplicity ablation catheter, Medtronic Inc. Minneapolis, Minnesota, USA)

Primary Outcome Measures

Name	Time	Method
Change in systolic blood pressure (ABPM mean value)	6 months

Trial Locations

Locations (1)

University of Leipzig Heart Center; 🇩🇪 Leipzig, Germany