Hypertension, Obstructive Sleep Apnea
Conditions
Keywords
hypertension, resistant, obstructive sleep apnea, renal denervation, continuous positive airway pressure therapy
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.
Interventions
DEVICERenal denervation with a catheter-based procedure (Symplicity® Catheter System)
Disruption of the renal nerves with a catheter-based procedure.
Sponsors
National Institute of Cardiology, Warsaw, Poland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood Pressure Reduction | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Responses to renal denervation (e.g., blood pressure reduction, sleep apnea course, metabolic assessment, cardiac changes) | Through 1 year |
Countries
Poland
Outcome results
None listed