Russian Study of the Effect of Continuous Positive Airway... | NCT00801671

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

NCT00801671

Sponsor

Russian Cardiology Research and Production Center

Status

Completed

Last Update Posted

Jun 17, 2011Estimated

Enrollment

50Actual

Phase

Phase 3

Conditions

Obstructive Sleep Apnea Syndrome
Hypertension

Interventions

cPAP

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Jun 19, 2008

First Submission Date that Met QC Criteria

Dec 2, 2008

First Posted Date

Dec 3, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2011

Last Update Posted Date

Jun 17, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator		Procedure: cPAP
2	Sham Comparator		Procedure: cPAP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cPAP	Procedure	After reaching target level of BP patients will be randomized in active group (cPAP) and control group (sham-cPAP)	1 2

Outcomes Module

Primary Outcomes

Measure	Description	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alexandr Yu Litvin, MD	Russian Cardiology Research and Production Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Russian Cardiologe Research and Production Complex		Moscow		121552	Russia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23690688	Derived	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.

ID	Term
D020181	Sleep Apnea, Obstructive
D006973	Hypertension

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases