Tracking Information
Start Date ICMJE | September 2008 |
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Estimated Primary Completion Date | August 2010 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: December 2, 2008) | Ambulatory blood pressure monitoring over 24 hours, at inclusion visit (day=0), before cPAP (3-9 weeks) and after 3 weeks of cPAP. [ Time Frame: 24 hours ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00801671 on ClinicalTrials.gov Archive Site |
Descriptive Information
Brief Title ICMJE | Russian Study of the Effect of Continuous Positive Airway Pressure (CPAP) in Hypertension |
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Official Title ICMJE | |
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. |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Condition ICMJE |
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Intervention ICMJE | Device: cPAP After reaching target level of BP patients will be randomized in active group (cPAP) and control group (sham-cPAP) |
Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 50 | ||||||||
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Estimated Completion Date | December 2010 | ||||||||
Estimated Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 18 Years to 80 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | Russian Federation |
Administrative Information
NCT ID ICMJE | NCT00801671 |
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Responsible Party | Kseniya Orlowa, Weinmann |
Study ID Numbers ICMJE | 1111 |
Study Sponsor ICMJE | Russian Cardiology Research and Production Center |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | Russian Cardiology Research and Production Center |