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

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

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea Syndrome; Hypertension
• Intervention / Treatment: Procedure: cPAP

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 121552
    • Russian Cardiologe Research and Production Complex

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1	Procedure: cPAP; After reaching target level of BP patients will be randomized in active group (cPAP) and control group (sham-cPAP)
Sham Comparator: 2	Procedure: cPAP; After reaching target level of BP patients will be randomized in active group (cPAP) and control group (sham-cPAP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Russian Cardiology Research and Production Center
• Investigators: Principal Investigator: Alexandr Yu Litvin, MD, Russian Cardiology Research and Production Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: June 19, 2008
• First Submitted That Met QC Criteria: December 2, 2008
• First Posted (Estimate): December 3, 2008

Study Record Updates

• Last Update Posted (Estimate): June 17, 2011
• Last Update Submitted That Met QC Criteria: June 15, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: obstructive sleep apnea syndrome; ambulatory blood pressure monitoring; hypertension; obstructive sleep apnea; systemic hypertension
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypertension; Syndrome; Apnea
• Other Study ID Numbers: 1111 (Prima Psychiatry internal research fund)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No