Clinical trial NCT00640536: Right Ventricular Function in Obstructive Sleep Apnea
Official title: The Evaluation of Subclinical Right Ventricular Dysfunction in Obstructive Sleep Apnea Patients Without Systemic and Pulmonary Arterial Hypertension Using Velocity Vector Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea, Obstructive
Lead sponsor: Florence Nightingale Hospital, Istanbul
Sponsor class: OTHER
First posted: 2008-03-21
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Tertiary care clinic, obstructive sleep apnea patients

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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Florence Nightingale Hospital
state: Caglayan
Study officials:
affiliation: T.C. Istanbul Bilim University, Florence Nightingale Hospital, Division of Cardiology
name: Saide Aytekin
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/j.amjcard.2006.12.052. Epub 2007 Mar 20.
citation: 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.
citation: 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.
citation: 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.