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

This study has been completed.
Sponsor:
Information provided by:
Russian Cardiology Research and Production Center
ClinicalTrials.gov Identifier:
NCT00801671
First received: June 19, 2008
Last updated: June 15, 2011
Last verified: June 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Obstructive Sleep Apnea Syndrome
Hypertension
 Procedure: cPAP
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Russian Cardiology Research and Production Center:

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. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: September 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00801671

Locations
Russian Federation
Russian Cardiologe Research and Production Complex
Moscow, Russian Federation, 121552
Sponsors and Collaborators
Russian Cardiology Research and Production Center
Investigators
Principal Investigator: Alexandr Yu Litvin, MD Russian Cardiology Research and Production Center
  More Information

No publications provided

Responsible Party: Kseniya Orlowa, Weinmann
ClinicalTrials.gov Identifier: NCT00801671     History of Changes
Other Study ID Numbers: 1111
Study First Received: June 19, 2008
Last Updated: June 15, 2011
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by Russian Cardiology Research and Production Center:
obstructive sleep apnea
obstructive sleep apnea syndrome
hypertension
systemic hypertension
ambulatory blood pressure monitoring

Additional relevant MeSH terms:
Apnea
Hypertension
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 22, 2013