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Preventive Effects of Bosentan on the Systemic Cardiovascular Consequence of Sleep Apnea (BOSAS)

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.
 
ClinicalTrials.gov Identifier: NCT00777985
Recruitment Status : Completed
First Posted : October 23, 2008
Last Update Posted : May 21, 2014
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
Actelion
Information provided by (Responsible Party):
University Hospital, Grenoble

Study Description
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Brief Summary:

The study will compared the effects of bosentan, an endothelin receptor antagonist, and nasal continuous positive airway pressure (nCPAP), obstructive sleep apnea current reference treatment, on diastolic blood pressure in untreated mildly hypertensive sleep apnea patients.

The hypothesis is that blocking endothelin receptors with a drug will have the same systemic blood pressure lowering effect than nCPAP in sleep apnea patients.


Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Hypertension Drug: bosentan Device: nasal continuous positive airway pressure (CPAP) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cardiovascular Consequences of Obstructive Sleep Apnea (OSA): Role of Endothelin and Preventive Effects of Bosentan
Study Start Date : December 2007
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
Drug Information available for: Bosentan

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: bosentan
62.5 mg b.i.d for 4 weeks
Other Name: TRACLEER
Active Comparator: 2 Device: nasal continuous positive airway pressure (CPAP)
Daily application throughout sleep for 4 weeks


Outcome Measures
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Primary Outcome Measures :
  1. 24 hour mean diastolic blood pressure [ Time Frame: before and after each treatment completion (4 weeks) ]

Secondary Outcome Measures :
  1. Peripheral Arterial Tonometry measure [ Time Frame: before and after each treatment completion (4 weeks) ]
  2. mean 24 hour systemic systolic blood pressure [ Time Frame: before and after each treatment completion (4 weeks) ]
  3. mean 24 hour nocturnal blood pressure [ Time Frame: before and after each treatment completion (4 weeks) ]
  4. carotid Intima Media Thickness [ Time Frame: before and after each treatment completion (4 weeks) ]
  5. Circulating inflammation markers (RANTES, MCP-1, TNF-alpha, INF-gamma, IL-6, IL-10 and TGF-gamma [ Time Frame: before and after each treatment completion (4 weeks) ]
  6. Circulating Big ET1 and ET1 levels [ Time Frame: before and after each treatment completion (4 weeks) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented obstructive sleep apnea
  • with untreated mild systemic hypertension

Exclusion Criteria:

  • pregnancy or lactation
  • daytime alveolar hypoventilation
  • severe arterial hypertension (systolic pressure > 180 mmHg; diastolic pressure > 110 mmHg)
  • treatment with anti-hypertensive drugs
  • cardiovascular disorder other than mild hypertension
  • severe daytime sleepiness (score on the EPWORTH sleepiness scale ≥15) or at-risk occupation
  • contra-indication to nCPAP treatment
  • known allergy to bosentan
  • active treatment with a drug whose efficacy is reduced by cytochromes P450, 2C9, 3A4 and2C19 isoenzyme activation
  • active treatment with a drug acting on systemic arterial blood pressure or endothelial function
  • liver or kidney dysfunction
Contacts and Locations
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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): NCT00777985


Locations
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France
CHU de Grenoble
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Institut National de la Santé Et de la Recherche Médicale, France
Actelion
Investigators
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Principal Investigator: Sandrine H Launois, MD PhD University Hospital, Grenoble
More Information
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT00777985    
Other Study ID Numbers: 0722
2007-005333-11 ( Registry Identifier: EudraCT number )
First Posted: October 23, 2008    Key Record Dates
Last Update Posted: May 21, 2014
Last Verified: May 2014
Keywords provided by University Hospital, Grenoble:
Cardiovascular system
Sleep
Endothelial function
Endothelin system
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
 Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Bosentan
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action