Renal Sympathetic Denervation in Mild Refractory Hypertension

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

Completed

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Key information

Conditions

Refractory Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Leipzig Heart Center

Leipzig, 04289, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Sham Procedure

Other

Primary outcomes

Change in systolic blood pressure (ABPM mean value)

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Registry information

Official study title

Renal Sympathetic Denervation in Patients With Mild Refractory Hypertension

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Aug 2, 2012
Registry last updated: Oct 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed