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Right Ventricular Function in Obstructive Sleep Apnea

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00640536
First Posted: March 21, 2008
Last Update Posted: December 1, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Florence Nightingale Hospital, Istanbul
  Purpose
The purpose of this study is to determine the structural and functional cardiac alterations in obstructive sleep apne (OSA) independent from systemic and pulmonary arterial hypertension and their correlation to the severity of OSA.

Condition
Sleep Apnea, Obstructive

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Evaluation of Subclinical Right Ventricular Dysfunction in Obstructive Sleep Apnea Patients Without Systemic and Pulmonary Arterial Hypertension Using Velocity Vector Imaging

Resource links provided by NLM:


Further study details as provided by Florence Nightingale Hospital, Istanbul:

Enrollment: 53
Study Start Date: June 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Newly diagnosed obstructive sleep apnea patients without systemic and pulmonary arterial hypertension
2
Age, sex and and body mass index-matched matched healthy subjects

Detailed Description:
Many risk factors for OSA, such as male gender, obesity, and increasing age are the same as for cardiovascular diseases. This fact makes it more difficult to establish a causal relationship between OSA and cardiovascular diseases. The relationship between OSA and right ventricular (RV) function is controversial. RV dysfunction may be a result of chronic intermittent hypoxia and hypercapnia during apneic episodes. It may also occur secondary to left ventricular dysfunction as a result of increased afterload and sympathetic activity which causes secondary hypertension. As systemic hypertension is one of the most accompanying and contributing factors in OSA along with obesity, we tried to compare the effects of newly diagnosed OSA on RV function with an age and body mass index- matched control group.
  Eligibility

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Tertiary care clinic, obstructive sleep apnea patients
Criteria

Inclusion Criteria:

For OSA patients (group1)

  • Apnea Hypopnea Index equal or more than 15
  • Epworth sleepiness scale equal or more than 10
  • No previous treatment for OSA

Exclusion Criteria:

  • Age < 18 years
  • Known hypertension, or 24-hour mean blood pressure of 135 and/or 85 mmHg or more
  • Mean pulmonary artery pressure > 25 mmHg
  • Diabetes mellitus
  • Left ventricular ejection fraction < 60%
  • Moderate to severe valvular disease
  • Cardiomyopathy
  • Renal failure
  • Coronary artery disease
  • Obstructive or restrictive lung disease demonstrated on pulmonary function test
  • Connective-tissue or chronic thromboembolic disease
  • Pericardial disease
  • Cancer and/or other important comorbidities with an expected survival < 2 years
  • Suboptimal echocardiographic images for measurements
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00640536


Locations
Turkey
Florence Nightingale Hospital
Istanbul, Caglayan, Turkey, 34381
Sponsors and Collaborators
Florence Nightingale Hospital, Istanbul
Investigators
Principal Investigator: Saide Aytekin T.C. Istanbul Bilim University, Florence Nightingale Hospital, Division of Cardiology
  More Information

Publications:
Responsible Party: Prof. Dr. Saide Aytekin, T.C. Istanbul Bilim University; Florence Nightingale Hospital
ClinicalTrials.gov Identifier: NCT00640536     History of Changes
Other Study ID Numbers: AT-1974/1
First Submitted: March 17, 2008
First Posted: March 21, 2008
Last Update Posted: December 1, 2008
Last Verified: November 2008

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