Right Ventricular Function in Obstructive Sleep Apnea

November 28, 2008 updated by: Florence Nightingale Hospital, Istanbul

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

53

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Caglayan
      • Istanbul, Caglayan, Turkey, 34381
        • Florence Nightingale Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Tertiary care clinic, obstructive sleep apnea patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Florence Nightingale Hospital, Istanbul

Investigators

  • Principal Investigator: Saide Aytekin, T.C. Istanbul Bilim University, Florence Nightingale Hospital, Division of Cardiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

March 17, 2008

First Submitted That Met QC Criteria

March 20, 2008

First Posted (Estimate)

March 21, 2008

Study Record Updates

Last Update Posted (Estimate)

December 1, 2008

Last Update Submitted That Met QC Criteria

November 28, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AT-1974/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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