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OpenTrials
Completed

NCT Number: NCT03267667

Effect of OSA on RV Heamodynamics and Function

Correlation of severity of obstructive sleep apnea and function of the right ventricle by means of 2D echocardiography and cardiac MRI

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut university

Asyut, 71515, Egypt

About this study

Obstructive sleep apnea (OSA) is a frequently under diagnosed condition that has emerged as an increasing medical problem with important social and financial implications worldwide. OSA is a well established risk factor for systemic hypertension , myocardial infarction or stroke.

Obstructive sleep apnea syndrome (OSAS) is characterized by repetitive collapse of the upper airway during sleep .The obstructive apneic event is associated with considerable breathing efforts against a totally or partially occluded upper airway, and apnea is terminated by an arousal and heavy snoring as airflow is restored. Severity of OSAS is described according to total number of apneas and hyperpneas per hour of sleep, which is named as the apnea-hypopnea index (AHI).

Cardiovascular disturbances are the most serious complications of OSAS. These complications include heart failure, acute myocardial infarction, nocturnal arrhythmias, stroke, systemic and pulmonary hypertension. All these cardiovascular complications increase morbidity and mortality of OSAS.

Currently, sleep apnea is accepted as one of the identifiable causes of hypertension. Also, OSAS is closely associated with obesity and ageing.

There is conclusive evidence that OSAS influences right heart function (the pathophysiological consequences of sleep apnea-hypopnea might result in an imbalance in myocardial oxygen delivery/consumption ratio, activation of sympathetic and other neurohormonal systems, and increased right and left ventricular after load )

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects diagnosed as OSA with age range from 18 to 70 years
  • Glomerular filtration rate (MDRD formula-based) > 60 ml/min
  • Arterial hypertension diagnosed according to the European Society of Hypertension 2013 Guidelines.

Exclusion criteria

  • Mental illness
  • Acute and chronic inflammation
  • Heart failure III or IV grade
  • Chronic administration of drugs with confirmed nephrotoxicity and/or sympathicomimetics
  • Obstructive and restrictive pulmonary diseases which may deteriorate the function of the respiratory system

Treatment and study plan

2D Echocardiography and cardiac MRI

Diagnostic Test

imaging of right ventricle by both modalities to assess right ventricle function accurately

Primary outcomes

  1. The RV function in subjects with OSA compared with healthy persons

    Time frame: 1 year

    Assessment of RV function by cardiac MRI in OSA patients and healthy volunteers

Secondary outcomes

  1. Early detection of any impairment in cardiac global function in the participants before causing symptoms.

    Time frame: 1 year

    Cardiac MRI help to detect early cardiac dysfunction before symptoms appear which causes. Early detection equal early management which will improve the cardiac prognosis

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Effect of Obstructive Sleep Apnea on Right Ventricle Heamodynamics and Function

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Aug 30, 2017
Registry last updated
Apr 8, 2021

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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