Effect of OSA on RV Heamodynamics and Function

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT03267667
Collaborator
(none)
100
1
24
4.2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: 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 Design

Study Type:
Observational
Actual Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Effect of Obstructive Sleep Apnea on Right Ventricle Heamodynamics and Function
Actual Study Start Date :
Jan 1, 2019
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Jan 1, 2021

Arms and Interventions

Arm Intervention/Treatment
obstructive sleep apnea patients

number of 90 patients will be investigated by 2D echocardiography and cardiac MRI to determine the right ventricle function

Diagnostic Test: 2D Echocardiography and cardiac MRI
imaging of right ventricle by both modalities to assess right ventricle function accurately

healthy volunteers

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

Diagnostic Test: 2D Echocardiography and cardiac MRI
imaging of right ventricle by both modalities to assess right ventricle function accurately

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assiut university Assiut Egypt 71515

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Director: Salwa R. Demitry, Assiut University
  • Study Director: Aliaë A. Mohamid, Assiut University
  • Study Director: Ayman k. Hassan, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mary Zakher Bakhiet, resident doctor, Assiut University
ClinicalTrials.gov Identifier:
NCT03267667
Other Study ID Numbers:
  • 17100300
First Posted:
Aug 30, 2017
Last Update Posted:
Apr 8, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 8, 2021