Russian Study of the Effect of Continuous Positive Airway Pressure (CPAP) in Hypertension

Tracking Information

Start Date  ICMJESeptember 2008
Estimated Primary Completion DateAugust 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  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00801671 on Archive Site

Descriptive Information

Brief Title  ICMJERussian Study of the Effect of Continuous Positive Airway Pressure (CPAP) in Hypertension
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 PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Condition  ICMJE
  • Obstructive Sleep Apnea Syndrome
  • Hypertension
Intervention  ICMJEDevice: cPAP
After reaching target level of BP patients will be randomized in active group (cPAP) and control group (sham-cPAP)
Study Arms / Comparison Groups
  • 1: Active Comparator
    Intervention: Device: cPAP
  • 2: Sham Comparator
    Intervention: Device: cPAP

Recruitment Information

Estimated Enrollment  ICMJE50
Estimated Completion DateDecember 2010
Estimated Primary Completion DateAugust 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Ages18 Years to 80 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Igor Kolos, PhD414-63-25 ext +7(495)
Contact: Zulfiya Skobeleva414-60-03 ext +7(495)
Location Countries  ICMJERussian Federation

Administrative Information

Responsible PartyKseniya Orlowa, Weinmann
Study ID Numbers  ICMJE1111
Study Sponsor  ICMJERussian Cardiology Research and Production Center
Collaborators  ICMJE 
Investigators  ICMJE 
Information Provided ByRussian Cardiology Research and Production Center