Renal Denervation in Patients With Resistant Hypertension and Obstructive Sleep Apnea
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ClinicalTrials.gov Identifier: NCT01366625 |
Recruitment Status
:
Completed
First Posted
: June 6, 2011
Last Update Posted
: January 26, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension Obstructive Sleep Apnea | Device: Renal denervation with a catheter-based procedure (Symplicity® Catheter System) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Effects of Renal Denervation on Blood Pressure and Clinical Course of Obstructive Sleep Apnea in Patients With Resistant Hypertension |
Actual Study Start Date : | July 2011 |
Actual Primary Completion Date : | February 8, 2016 |
Actual Study Completion Date : | November 28, 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Renal Denervation
Renal Denervation and maintenance of anti-hypertensive medications and continuous positive airway pressure therapy
|
Device: Renal denervation with a catheter-based procedure (Symplicity® Catheter System)
Disruption of the renal nerves with a catheter-based procedure.
Other Name: Renal Denervation (Symplicity® Catheter System)
|
No Intervention: Maintenance of Medications
Maintenance of anti-hypertensive medications and continuous positive airway pressure therapy
|
- Blood Pressure Reduction [ Time Frame: 3 months ]
- Responses to renal denervation (e.g., blood pressure reduction, sleep apnea course, metabolic assessment, cardiac changes) [ Time Frame: Through 1 year ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01366625
Poland | |
Institute of Cardiology | |
Warsaw, Poland, 04-628 |
Principal Investigator: | Aleksander Prejbisz, M.D., Ph.D. | Institute of Cardiology |
Responsible Party: | Institute of Cardiology, Warsaw, Poland |
ClinicalTrials.gov Identifier: | NCT01366625 History of Changes |
Other Study ID Numbers: |
OSA-Denerv1 |
First Posted: | June 6, 2011 Key Record Dates |
Last Update Posted: | January 26, 2017 |
Last Verified: | January 2017 |
Keywords provided by Institute of Cardiology, Warsaw, Poland:
hypertension, resistant obstructive sleep apnea renal denervation continuous positive airway pressure therapy |
Additional relevant MeSH terms:
Hypertension Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Vascular Diseases Cardiovascular Diseases Respiration Disorders |
Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |