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

Study Overview
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Brief Summary
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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.

Detailed Description
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It is now well known that cardiovascular risks are increased in patients with obstructive sleep apnea syndrome (OSAS). Also a link has already been demonstrated between OSAS and hypertension. Nowadays, the most efficient treatment of the OSAS is the continuous Positive Airway Pressure (cPAP). Several studies have also shown that cPAP could reduce arterial blood pressure of about 3,3 mmHg in OSAS patients. Unfortunately, 40% of the patients either refuse being treated by cPAP or give up treatment. In parallel, alternative medications are proposed to patients with moderate OSAS and hypertension, in order to decrease their cardiovascular risks. A study led on rats has shown the superiority of the beta adrenergic blocking agents in the decrease of hypertension in OSAS patients. Our study has also the objective to compare the effects of Valsartan and cPAP on hypertension in OSAS patients. Those one will be randomized either in the group treatment by Valsartan and then by cPAP or in the group treatment by cPAP and then Valsartan (cross-over study).

Official Title
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Comparative Study of Effect of Valsartan 160mg Treatment Versus Continuous Positive Airway Pressure on Arterial Blood Pressure in Patients Who Have an Obstructive Sleep Apnea Syndrome and a Weak or Moderate Hypertension.

Conditions
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Hypertension,, Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Continuous positive airway pressure (CPAP)
* Drug: Valsartant treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>8 weeks of Valsartant treatment, 4 weeks of washout, 8 weeks of CPAP and 8 weeks of Valsartant plus CPAP treatments | Device: Continuous positive airway pressure (CPAP)<br>* 8 weeks of CPAP<br>* Other names: CPAP treatment;Drug: Valsartant treatment<br>* 8 weeks of Valsartant treatment (160 mg / day)<br>|
| Experimental: 2<br>8 weeks of CPAP , 4 weeks of washout, 8 weeks of Valsartant treatment and 8 weeks of Valsartant plus CPAP treatments | Device: Continuous positive airway pressure (CPAP)<br>* 8 weeks of CPAP<br>* Other names: CPAP treatment;Drug: Valsartant treatment<br>* 8 weeks of Valsartant treatment (160 mg / day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ambulatory blood pressure monitoring over 24 hours, at inclusion visit (day=0), 8 weeks, 12 weeks, and 20 weeks |  | 24 h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical blood pressure measurement at inclusion, 8 weeks, 12 weeks, and 20 weeks; pulse wave speed at inclusion, 8 weeks, 12 weeks, and 20 weeks; baroreceptor reflex at inclusion, 8 weeks, 12 weeks, and 20 weeks. |  | 1 h | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obstructive sleep apnea, hypertension, ambulatory bloop pressure monitoring