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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
Sponsor:
Information provided by (Responsible Party):
Institute of Cardiology, Warsaw, Poland

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Hypertension Obstructive Sleep Apnea Device: Renal denervation with a catheter-based procedure (Symplicity® Catheter System) Not Applicable

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Blood Pressure Reduction [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Responses to renal denervation (e.g., blood pressure reduction, sleep apnea course, metabolic assessment, cardiac changes) [ Time Frame: Through 1 year ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Poland
Institute of Cardiology
Warsaw, Poland, 04-628
Sponsors and Collaborators
Institute of Cardiology, Warsaw, Poland
Investigators
Principal Investigator: Aleksander Prejbisz, M.D., Ph.D. Institute of Cardiology
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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