Right Ventricular Function in Obstructive Sleep Apnea

Sleep Apnea, Obstructive Clinical Trial

Official title:

The Evaluation of Subclinical Right Ventricular Dysfunction in Obstructive Sleep Apnea Patients Without Systemic and Pulmonary Arterial Hypertension Using Velocity Vector Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00640536
• Other study ID #: AT-1974/1
• Status: Completed
• Phase: N/A
• First received: March 17, 2008
• Last updated: November 28, 2008
• Start date: June 2006
• Est. completion date: June 2008

Study information

• Verified date: November 2008
• Source: Florence Nightingale Hospital, Istanbul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of HealthTurkey: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Turkey	Florence Nightingale Hospital	Istanbul	Caglayan

Sponsors (1)

Lead Sponsor	Collaborator
Florence Nightingale Hospital, Istanbul

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

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. Epub 2007 Mar 20. — View Citation

Tavil Y, Kanbay A, Sen N, Ciftçi TU, Abaci A, Yalçin MR, Köktürk 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. Epub 2006 Oct 20. — View Citation

Tavil Y, Kanbay A, Sen N, Ulukavak Ciftçi T, Abaci A, Yalçin MR, Köktürk 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. — View Citation