Clinical trial NCT00801671: Russian Study of the Effect of Continuous Positive Airway Pressure (CPAP) in Hypertension
Official title: Study of Independent Role of Continuous Positive Airway Pressure Therapy on Systemic Arterial Pressure in Patients With Sleep Apnea Syndrome and Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obstructive Sleep Apnea Syndrome
Hypertension
Keywords: obstructive sleep apnea
obstructive sleep apnea syndrome
hypertension
systemic hypertension
ambulatory blood pressure monitoring
Lead sponsor: Russian Cardiology Research and Production Center
Sponsor class: OTHER
First posted: 2008-12-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether CPAP is effective in the treatment of systemic hypertension.

Detailed description: 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 in OSAS patients. But level of blood pressure (BP), drug treatment were not equal between groups and it's difficult to single out independent role of cPAP.

Our study has the objective to compare the effects of cPAP on hypertension in OSAS patients. After 3-9 weeks of antihypertensive treatment (valsartan and amlodipine) those one who reached target level of BP will be randomized either in the group "treatment by cPAP" or in the group "treatment by cham-cPAP" for 3 weeks and then we'll perform cross-over.

Eligibility 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)
* negative pregnancy test
* ambulatory patient
* patient who have signed the informed consent form

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 and/or amlodipine
* patient treated with lithium
* patient on tutelle or curatelle
* patient kept in detention, major protected by the law, hospitalized person patient currently participating in another clinical trial

Primary outcomes:
measure: Ambulatory blood pressure monitoring over 24 hours, at inclusion visit (day=0), before cPAP (3-9 weeks) and after 3 weeks of cPAP.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Russian Cardiologe Research and Production Complex
Study officials:
affiliation: Russian Cardiology Research and Production Center
name: Alexandr Yu Litvin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Litvin AY, Sukmarova ZN, Elfimova EM, Aksenova AV, Galitsin PV, Rogoza AN, Chazova IE. Effects of CPAP on "vascular" risk factors in patients with obstructive sleep apnea and arterial hypertension. Vasc Health Risk Manag. 2013;9:229-35. doi: 10.2147/VHRM.S40231. Epub 2013 May 10.