Renal Sympathetic Denervation in Mild Refractory Hypertension

Refractory Hypertension Clinical Trial

Official title:

Renal Sympathetic Denervation in Patients With Mild Refractory Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01656096
• Other study ID #: RSD-Leipzig
• Status: Completed
• Phase: Phase 4
• First received: July 31, 2012
• Last updated: October 27, 2016
• Start date: July 2012
• Est. completion date: July 2014

Study information

• Verified date: October 2016
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Refractory Hypertension

Intervention

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

Other:
• Sham procedure

Locations

Country	Name	City	State
Germany	University of Leipzig Heart Center	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in systolic blood pressure (ABPM mean value)		6 months	No

External Links

•   Publication of study