Effect of OSA on RV Heamodynamics and Function

Completed

• Conditions: Sleep Apnea, Obstructive
• Interventions: Diagnostic Test: 2D Echocardiography and cardiac MRI

• Registration Number: NCT03267667
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed Description

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 )

Study Timeline

• Study First Submitted: 2017-08-25
• Study First Submitted QC: 2017-08-29
• Study First Posted: 2017-08-30
• Study Start: 2019-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-01-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-05
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
obstructive sleep apnea patients	2D Echocardiography and cardiac MRI	number of 90 patients will be investigated by 2D echocardiography and cardiac MRI to determine the right ventricle function
healthy volunteers	2D Echocardiography and cardiac MRI	number of 10 subjects will be investigated by 2D echocardiography and cardiac MRI to determine right ventricular function in healthy persons have risk factors other than cardiac or lung diseases

Primary Outcome Measures

Name	Time	Method
The RV function in subjects with OSA compared with healthy persons	1 year	Assessment of RV function by cardiac MRI in OSA patients and healthy volunteers

Secondary Outcome Measures

Name	Time	Method
Early detection of any impairment in cardiac global function in the participants before causing symptoms.	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

Trial Locations

Locations (1)

Assiut university; 🇪🇬 Assiut, Egypt