Effects of Continuous Positive Airway Pressure and Valsartan Treatments on Arterial Blood Pressure in OSAS Patients

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The main objective of the study is to compare the decrease of mean arterial blood pressure over 24 hours in patients having obstructive sleep apnea syndrome and weak or moderate hypertension, treated by Valsartan 160mg per day versus continuous Positive Airway Pressure.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Grenoble
• Treatments: Valsartan

Criteria

Inclusion Criteria:

• male/female over than 18 years old

• patient with an obstructive sleep apnea (apnea-hypopnea index > or equal to 15)

• patient with weak or moderate hypertension (140 <= SBP < 180 mmHg and 90 <= DBP < 110 mmHg). Patient with antihypertensive monotherapy must stop their treatment and respect a washout period of at least 4 weeks before the screening visit. For patient treated by antialdosterone, the washout period will be of at least 8 weeks.

• negative pregnancy test

• ambulatory patient

• patient who have signed the informed consent form

• patient affiliated to social security

Exclusion Criteria:

• pregnant or nursing woman

• woman who refuses to use contraceptive method

• acute hepatic failure, biliary cirrhosis, cholestasis

• clearance of Cockcroft < 30 ml/min/1.73m2

• kaliemia >= 5.5 mmol/l

• acute hypertension (SBP>= 180 mmHg and/or DBP >= 110 mmHg)

• acute daytime sleepiness (Epworth rating scale > 15)

• patient with a profession that is inconsistent with the continuous positive airway pressure (CPAP) treatment

• known cardiovascular pathologies

• contraindication to CPAP

• allergy to Valsartan

• patient treated with lithium

• patient treated with drug(s) acting on arterial blood pressure

• patient on tutelle or curatelle

• patient kept in detention, major protected by the law, hospitalised person

• patient currently participating in another clinical trial