Right Ventricular Function in Obstructive Sleep Apnea

NCT00640536 | Completed DMC

• 1 other identifier: AT-1974/1
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep Apnea, Obstructive

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Tertiary care clinic, obstructive sleep apnea patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Florence Nightingale Hospital, Istanbul: lead

Study Sites (1)

Florence Nightingale Hospital

Istanbul, Caglayan, 34381, Turkey (Türkiye)

Location

Related Publications (4)

• Otto ME, Belohlavek M, Romero-Corral A, Gami AS, Gilman G, Svatikova A, Amin RS, Lopez-Jimenez F, Khandheria BK, Somers VK. Comparison of cardiac structural and functional changes in obese otherwise healthy adults with versus without obstructive sleep apnea. Am J Cardiol. 2007 May 1;99(9):1298-302. doi: 10.1016/j.amjcard.2006.12.052. Epub 2007 Mar 20.

  PMID: 17478161 BACKGROUND

• Okuda N, Ito T, Emura N, Suwa M, Hayashi T, Yoneda H, Kitaura Y. Depressed myocardial contractile reserve in patients with obstructive sleep apnea assessed by tissue Doppler imaging with dobutamine stress echocardiography. Chest. 2007 Apr;131(4):1082-9. doi: 10.1378/chest.06-2444.

  PMID: 17426213 BACKGROUND

• Tavil Y, Kanbay A, Sen N, Ulukavak Ciftci T, Abaci A, Yalcin MR, Kokturk O, Cengel A. The relationship between aortic stiffness and cardiac function in patients with obstructive sleep apnea, independently from systemic hypertension. J Am Soc Echocardiogr. 2007 Apr;20(4):366-72. doi: 10.1016/j.echo.2006.09.005.

  PMID: 17400115 BACKGROUND

• Tavil Y, Kanbay A, Sen N, Ciftci TU, Abaci A, Yalcin MR, Kokturk O, Cengel A. Comparison of right ventricular functions by tissue Doppler imaging in patients with obstructive sleep apnea syndrome with or without hypertension. Int J Cardiovasc Imaging. 2007 Aug;23(4):469-77. doi: 10.1007/s10554-006-9168-6. Epub 2006 Oct 20.

  PMID: 17054014 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Saide Aytekin

  T.C. Istanbul Bilim University, Florence Nightingale Hospital, Division of Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 17, 2008
• First Posted: March 21, 2008
• Study Start: June 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: December 1, 2008

Record last verified: 2008-11

Locations

TU (1)