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

Sponsor

University Hospital, Grenoble (Other)

Overall Status

Completed

CT.gov ID

NCT00777985

Collaborator

Institut National de la Santé Et de la Recherche Médicale, France (Other), Actelion (Industry)

Enrollment

Location

Arms

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Dec 1, 2007

Actual Primary Completion Date :

Jan 1, 2012

Actual Study Completion Date :

Jan 1, 2012

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 1

Drug: bosentan

62.5 mg b.i.d for 4 weeks

Other Names:

TRACLEER

Active Comparator: 2

Device: nasal continuous positive airway pressure (CPAP)

Daily application throughout sleep for 4 weeks

Outcome Measures

Primary Outcome Measures

24 hour mean diastolic blood pressure [before and after each treatment completion (4 weeks)]

Secondary Outcome Measures

Peripheral Arterial Tonometry measure [before and after each treatment completion (4 weeks)]
mean 24 hour systemic systolic blood pressure [before and after each treatment completion (4 weeks)]
mean 24 hour nocturnal blood pressure [before and after each treatment completion (4 weeks)]
carotid Intima Media Thickness [before and after each treatment completion (4 weeks)]
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)]
Circulating Big ET1 and ET1 levels [before and after each treatment completion (4 weeks)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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