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

Primary Purpose

Obstructive Sleep Apnea Syndrome, Hypertension

Status

Completed

Phase

Phase 3

Locations

Russian Federation

Study Type

Interventional

Intervention

cPAP

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea Syndrome focused on measuring obstructive sleep apnea, obstructive sleep apnea syndrome, hypertension, systemic hypertension, ambulatory blood pressure monitoring

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Russian Cardiologe Research and Production Complex

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Ambulatory blood pressure monitoring over 24 hours, at inclusion visit (day=0), before cPAP (3-9 weeks) and after 3 weeks of cPAP.

Secondary Outcome Measures

Full Information

NCT ID

NCT00801671

First Posted

June 19, 2008

Last Updated

June 15, 2011

Sponsor

Russian Cardiology Research and Production Center

1. Study Identification

Unique Protocol Identification Number

NCT00801671

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Russian Cardiology Research and Production Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea Syndrome, Hypertension

Keywords

obstructive sleep apnea, obstructive sleep apnea syndrome, hypertension, systemic hypertension, ambulatory blood pressure monitoring

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Sham Comparator

Intervention Type

Procedure

Intervention Name(s)

cPAP

Intervention Description

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

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexandr Yu Litvin, MD

Organizational Affiliation

Russian Cardiology Research and Production Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Russian Cardiologe Research and Production Complex

City

Moscow

ZIP/Postal Code

121552

Country

Russian Federation

12. IPD Sharing Statement

Citations:

PubMed Identifier

23690688

Citation

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.

Results Reference

derived

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

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