Effect of OSA on RV Heamodynamics and Function

NCT ID: NCT03267667

Last Updated: 2021-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2021-01-01

Brief Summary

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

Detailed Description

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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 )

Conditions

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Sleep Apnea, Obstructive

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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obstructive sleep apnea patients

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

2D Echocardiography and cardiac MRI

Intervention Type DIAGNOSTIC_TEST

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

2D Echocardiography and cardiac MRI

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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2D Echocardiography and cardiac MRI

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mary Zakher Bakhiet

resident doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Salwa R. Demitry

Role: STUDY_DIRECTOR

Assiut University

Aliaƫ A. Mohamid

Role: STUDY_DIRECTOR

Assiut University

Ayman k. Hassan

Role: STUDY_DIRECTOR

Assiut University

Locations

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Assiut university

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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Nieto FJ, Young TB, Lind BK, Shahar E, Samet JM, Redline S, D'Agostino RB, Newman AB, Lebowitz MD, Pickering TG. Association of sleep-disordered breathing, sleep apnea, and hypertension in a large community-based study. Sleep Heart Health Study. JAMA. 2000 Apr 12;283(14):1829-36. doi: 10.1001/jama.283.14.1829.

Reference Type BACKGROUND
PMID: 10770144 (View on PubMed)

Peppard PE, Young T, Palta M, Skatrud J. Prospective study of the association between sleep-disordered breathing and hypertension. N Engl J Med. 2000 May 11;342(19):1378-84. doi: 10.1056/NEJM200005113421901.

Reference Type BACKGROUND
PMID: 10805822 (View on PubMed)

Hung J, Whitford EG, Parsons RW, Hillman DR. Association of sleep apnoea with myocardial infarction in men. Lancet. 1990 Aug 4;336(8710):261-4. doi: 10.1016/0140-6736(90)91799-g.

Reference Type BACKGROUND
PMID: 1973968 (View on PubMed)

Palomaki H, Partinen M, Erkinjuntti T, Kaste M. Snoring, sleep apnea syndrome, and stroke. Neurology. 1992 Jul;42(7 Suppl 6):75-81; discussion 82.

Reference Type BACKGROUND
PMID: 1630643 (View on PubMed)

Guilleminault C, Tilkian A, Dement WC. The sleep apnea syndromes. Annu Rev Med. 1976;27:465-84. doi: 10.1146/annurev.me.27.020176.002341. No abstract available.

Reference Type BACKGROUND
PMID: 180875 (View on PubMed)

Lattimore JD, Celermajer DS, Wilcox I. Obstructive sleep apnea and cardiovascular disease. J Am Coll Cardiol. 2003 May 7;41(9):1429-37. doi: 10.1016/s0735-1097(03)00184-0.

Reference Type BACKGROUND
PMID: 12742277 (View on PubMed)

Malone S, Liu PP, Holloway R, Rutherford R, Xie A, Bradley TD. Obstructive sleep apnoea in patients with dilated cardiomyopathy: effects of continuous positive airway pressure. Lancet. 1991 Dec 14;338(8781):1480-4. doi: 10.1016/0140-6736(91)92299-h.

Reference Type BACKGROUND
PMID: 1683918 (View on PubMed)

Guilleminault C, Connolly SJ, Winkle RA. Cardiac arrhythmia and conduction disturbances during sleep in 400 patients with sleep apnea syndrome. Am J Cardiol. 1983 Sep 1;52(5):490-4. doi: 10.1016/0002-9149(83)90013-9.

Reference Type BACKGROUND
PMID: 6193700 (View on PubMed)

Weitzenblum E, Krieger J, Apprill M, Vallee E, Ehrhart M, Ratomaharo J, Oswald M, Kurtz D. Daytime pulmonary hypertension in patients with obstructive sleep apnea syndrome. Am Rev Respir Dis. 1988 Aug;138(2):345-9. doi: 10.1164/ajrccm/138.2.345.

Reference Type BACKGROUND
PMID: 3143285 (View on PubMed)

Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14.

Reference Type BACKGROUND
PMID: 12748199 (View on PubMed)

Levinson PD, McGarvey ST, Carlisle CC, Eveloff SE, Herbert PN, Millman RP. Adiposity and cardiovascular risk factors in men with obstructive sleep apnea. Chest. 1993 May;103(5):1336-42. doi: 10.1378/chest.103.5.1336.

Reference Type BACKGROUND
PMID: 8486007 (View on PubMed)

Ancoli-Israel S, Coy T. Are breathing disturbances in elderly equivalent to sleep apnea syndrome? Sleep. 1994 Feb;17(1):77-83. doi: 10.1093/sleep/17.1.77. No abstract available.

Reference Type BACKGROUND
PMID: 8191206 (View on PubMed)

Javaheri S. Central sleep apnea in congestive heart failure: prevalence, mechanisms, impact, and therapeutic options. Semin Respir Crit Care Med. 2005 Feb;26(1):44-55. doi: 10.1055/s-2005-864206.

Reference Type BACKGROUND
PMID: 16052417 (View on PubMed)

Other Identifiers

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17100300

Identifier Type: -

Identifier Source: org_study_id

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