Preventive Effects of Bosentan on the Systemic Cardiovascular Consequence of Sleep Apnea

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Grenoble
• Collaborators: Actelion; Institut National de la Santé Et de la Recherche Médicale, France
• Treatments: Bosentan

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