Renal Denervation in Patients With Resistant Hypertension and Obstructive Sleep Apnea

National Institute of Cardiology, Warsaw, Poland

Status: Completed

Conditions: Hypertension; Obstructive Sleep Apnea

Treatments: Device: Renal denervation with a catheter-based procedure (Symplicity® Catheter System)

Study type: Interventional

Funder types: Other

Identifiers

NCT01366625

OSA-Denerv1

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Renal Denervation

Experimental group

Description:

Renal Denervation and maintenance of anti-hypertensive medications and continuous positive airway pressure therapy

Treatment:

Device: Renal denervation with a catheter-based procedure (Symplicity® Catheter System)

Maintenance of Medications

No Intervention group

Description:

Maintenance of anti-hypertensive medications and continuous positive airway pressure therapy