Russian Study of the Effect of Continuous Positive Airway Pressure (CPAP) in Hypertension (NCT00801671) | Clinical Trial Compass
CompletedPhase 3
Russian Study of the Effect of Continuous Positive Airway Pressure (CPAP) in Hypertension
Russia50 participantsStarted 2008-09
Plain-language summary
The purpose of this study is to determine whether CPAP is effective in the treatment of systemic hypertension.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
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
Trial details
NCT IDNCT00801671
SponsorRussian Cardiology Research and Production Center