Effect of OSA on RV Heamodynamics and Function

Sleep Apnea, Obstructive Clinical Trial

Official title:

Effect of Obstructive Sleep Apnea on Right Ventricle Heamodynamics and Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03267667
• Other study ID #: 17100300
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: January 1, 2021

Study information

• Verified date: April 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 )

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 1, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (13)

Ancoli-Israel S, Coy T. Are breathing disturbances in elderly equivalent to sleep apnea syndrome? Sleep. 1994 Feb;17(1):77-83. Review. — View Citation

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. Epub 2003 May 14. Erratum in: JAMA. 2003 Jul 9;290(2):197. — View Citation

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. — View Citation

Guilleminault C, Tilkian A, Dement WC. The sleep apnea syndromes. Annu Rev Med. 1976;27:465-84. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Lattimore JD, Celermajer DS, Wilcox I. Obstructive sleep apnea and cardiovascular disease. J Am Coll Cardiol. 2003 May 7;41(9):1429-37. Review. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: JAMA 2002 Oct 23-30;288(16):1985. — View Citation

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

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. — View Citation

Weitzenblum E, Krieger J, Apprill M, Vallée 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The RV function in subjects with OSA compared with healthy persons	Assessment of RV function by cardiac MRI in OSA patients and healthy volunteers	1 year
Secondary	Early detection of any impairment in cardiac global function in the participants before causing symptoms.	Cardiac MRI help to detect early cardiac dysfunction before symptoms appear which causes. Early detection equal early management which will improve the cardiac prognosis	1 year