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OpenTrials
Completed

NCT Number: NCT00640536

Right Ventricular Function in Obstructive Sleep Apnea

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Florence Nightingale Hospital

Istanbul, Caglayan, 34381, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Florence Nightingale Hospital, Istanbul

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Mar 21, 2008
Registry last updated
Dec 1, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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