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

Hypertension Clinical Trial

— BOSAS  

Official title:

Cardiovascular Consequences of Obstructive Sleep Apnea (OSA): Role of Endothelin and Preventive Effects of Bosentan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00777985
• Other study ID #: 0722
• Secondary ID: 2007-005333-11
• Status: Completed
• Phase: Phase 2
• First received: October 22, 2008
• Last updated: May 20, 2014
• Start date: December 2007
• Est. completion date: January 2012

Study information

• Verified date: May 2014
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Hypertension
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• bosentan
62.5 mg b.i.d for 4 weeks

Device:
• nasal continuous positive airway pressure (CPAP)
Daily application throughout sleep for 4 weeks

Locations

Country	Name	City	State
France	CHU de Grenoble	Grenoble

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Actelion, Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hour mean diastolic blood pressure		before and after each treatment completion (4 weeks)	No
Secondary	Peripheral Arterial Tonometry measure		before and after each treatment completion (4 weeks)	No
Secondary	mean 24 hour systemic systolic blood pressure		before and after each treatment completion (4 weeks)	No
Secondary	mean 24 hour nocturnal blood pressure		before and after each treatment completion (4 weeks)	No
Secondary	carotid Intima Media Thickness		before and after each treatment completion (4 weeks)	No
Secondary	Circulating inflammation markers (RANTES, MCP-1, TNF-alpha, INF-gamma, IL-6, IL-10 and TGF-gamma		before and after each treatment completion (4 weeks)	No
Secondary	Circulating Big ET1 and ET1 levels		before and after each treatment completion (4 weeks)	No