Renal Denervation in Patients With Resistant Hypertension and Obstructive Sleep Apnea
Not Applicable
Completed
- Conditions
- HypertensionObstructive Sleep Apnea
- Interventions
- Device: Renal denervation with a catheter-based procedure (Symplicity® Catheter System)
- Registration Number
- NCT01366625
- Lead Sponsor
- National Institute of Cardiology, Warsaw, Poland
- Brief Summary
The purpose of this study is to investigate the clinical utility of renal denervation for the treatment of resistant hypertension coexisting with obstructive sleep apnea.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- >= 18 and =< 70 years of age.
- systolic blood pressure >=140mmHg (office);
- on 3 or more antihypertensive medications (including diuretic)
- mean daytime systolic ABPM >= 135 mmHg
- obstructive sleep apnea (AHI >=15 event/hour, indications for CPAP treatment)
Exclusion Criteria
- renal artery abnormalities
- eGFR < 60mL/min
- previous TIA, stroke, heart failure
- Type 1 diabetes
- ICD or pacemaker
- others
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Renal Denervation Renal denervation with a catheter-based procedure (Symplicity® Catheter System) Renal Denervation and maintenance of anti-hypertensive medications and continuous positive airway pressure therapy
- Primary Outcome Measures
Name Time Method Blood Pressure Reduction 3 months
- Secondary Outcome Measures
Name Time Method Responses to renal denervation (e.g., blood pressure reduction, sleep apnea course, metabolic assessment, cardiac changes) Through 1 year
Trial Locations
- Locations (1)
Institute of Cardiology
🇵🇱Warsaw, Poland