Russian Study of the Effect of Continuous Positive Airway Pressure (CPAP) in Hypertension
Study of Independent Role of Continuous Positive Airway Pressure Therapy on Systemic Arterial Pressure in Patients With Sleep Apnea Syndrome and Arterial Hypertension
1 other identifier
interventional
50
1 country
1
Brief Summary
The purpose of this study is to determine whether CPAP is effective in the treatment of systemic hypertension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2008
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2008
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedFirst Posted
Study publicly available on registry
December 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedJune 17, 2011
June 1, 2011
2.7 years
June 19, 2008
June 15, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ambulatory blood pressure monitoring over 24 hours, at inclusion visit (day=0), before cPAP (3-9 weeks) and after 3 weeks of cPAP.
24 hours
Study Arms (2)
1
ACTIVE COMPARATOR2
SHAM COMPARATORInterventions
After reaching target level of BP patients will be randomized in active group (cPAP) and control group (sham-cPAP)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Russian Cardiologe Research and Production Complex
Moscow, 121552, Russia
Related Publications (1)
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.
PMID: 23690688DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexandr Yu Litvin, MD
Russian Cardiology Research and Production Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 19, 2008
First Posted
December 3, 2008
Study Start
September 1, 2008
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
June 17, 2011
Record last verified: 2011-06