Right Ventricular Function in Obstructive Sleep Apnea - Full Text View

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:

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure Sleep Apnea

U.S. FDA Resources

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

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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:

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.

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.

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.

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.

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
Study First Received:	March 17, 2008
Last Updated:	November 28, 2008
Health Authority:	Turkey: Ministry of Health Turkey: Ethics Committee

Additional relevant MeSH terms:

Apnea
Sleep Apnea Syndromes
Ventricular Dysfunction, Right
Ventricular Dysfunction
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory

Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013