Status:
COMPLETED
Russian Study of the Effect of Continuous Positive Airway Pressure (CPAP) in Hypertension
Lead Sponsor:
Russian Cardiology Research and Production Center
Conditions:
Obstructive Sleep Apnea Syndrome
Hypertension
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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. Nowaday...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00801671
Start Date
September 1 2008
End Date
June 1 2011
Last Update
June 17 2011
Active Locations (1)
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1
Russian Cardiologe Research and Production Complex
Moscow, Russia, 121552