Renal Sympathetic Denervation in Mild Refractory Hypertension

University of Leipzig71 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Refractory Hypertension

Interventions

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

Sham procedureOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Leipzig Heart Center

Leipzig, Germany

Outcomes

Primary Outcomes

Change in systolic blood pressure (ABPM mean value)

Time frame: 6 months

Data from ClinicalTrials.gov

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