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

Hypertension Clinical Trial

Official title:

Study of Independent Role of Continuous Positive Airway Pressure Therapy on Systemic Arterial Pressure in Patients With Sleep Apnea Syndrome and Arterial Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00801671
• Other study ID #: 1111
• Status: Completed
• Phase: Phase 3
• First received: June 19, 2008
• Last updated: June 15, 2011
• Start date: September 2008
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: Russian Cardiology Research and Production Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether CPAP is effective in the treatment of systemic hypertension.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Procedure:
• cPAP
After reaching target level of BP patients will be randomized in active group (cPAP) and control group (sham-cPAP)

Locations

Country	Name	City	State
Russian Federation	Russian Cardiologe Research and Production Complex	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Russian Cardiology Research and Production Center

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No