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Renal Denervation in Patients With Resistant Hypertension and Obstructive Sleep Apnea

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01366625
First Posted: June 6, 2011
Last Update Posted: January 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Institute of Cardiology, Warsaw, Poland
  Purpose
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 Intervention
Hypertension Obstructive Sleep Apnea Device: Renal denervation with a catheter-based procedure (Symplicity® Catheter System)

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Institute of Cardiology, Warsaw, Poland:

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

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

Enrollment: 60
Actual Study Start Date: July 2011
Study Completion Date: November 28, 2016
Primary Completion Date: February 8, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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
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

Responsible Party: Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier: NCT01366625     History of Changes
Other Study ID Numbers: OSA-Denerv1
First Submitted: June 2, 2011
First Posted: June 6, 2011
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