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Renal Denervation in Patients With Resistant Hypertension and Obstructive Sleep Apnea

This study is currently recruiting participants.
Verified April 2013 by Institute of Cardiology, Warsaw, Poland
Sponsor:
Information provided by (Responsible Party):
Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier:
NCT01366625
First received: June 2, 2011
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  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 Phase
Hypertension
Obstructive Sleep Apnea
 Device: Renal denervation with a catheter-based procedure (Symplicity® Catheter System)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Blood Pressure Reduction [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Responses to renal denervation (e.g., blood pressure reduction, sleep apnea course, metabolic assessment, cardiac changes) [ Time Frame: Through 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01366625

Contacts
Contact: Aleksander Prejbisz, M.D., Ph.D. 48223434339 aprejbisz@ikard.pl

Locations
Poland
Institute of Cardiology Recruiting
Warsaw, Poland, 04-628
Contact: Jacek Kądziela, M.D., Ph.D.     48223434127     jkadziela@ikard.pl    
Sponsors and Collaborators
Institute of Cardiology, Warsaw, Poland
Investigators
Principal Investigator: Aleksander Prejbisz, M.D., Ph.D. Institute of Cardiology
  More Information

No publications provided

Responsible Party: Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier: NCT01366625     History of Changes
Other Study ID Numbers: OSA-Denerv1
Study First Received: June 2, 2011
Last Updated: April 22, 2013
Health Authority: Poland: Ministry of Science and Higher Education

Keywords provided by Institute of Cardiology, Warsaw, Poland:
hypertension, resistant
obstructive sleep apnea
renal denervation
continuous positive airway pressure therapy

Additional relevant MeSH terms:
Apnea
Hypertension
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 22, 2013