NCT03267667

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 30, 2017

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

2 years

First QC Date

August 25, 2017

Last Update Submit

April 5, 2021

Conditions

Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    1 year

Study Arms (2)

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

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

Interventions

2D Echocardiography and cardiac MRIDIAGNOSTIC_TEST

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

healthy volunteersobstructive sleep apnea patients

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will include 90 patients who are diagnosed as obstructive sleep apnea by sleep study and 10 healthy volunteers

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, 71515, Egypt

Location

Related Publications (13)

  • 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.

    PMID: 10770144BACKGROUND

  • 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.

    PMID: 10805822BACKGROUND

  • 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.

    PMID: 1973968BACKGROUND

  • 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.

    PMID: 1630643BACKGROUND

  • 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.

    PMID: 180875BACKGROUND

  • 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.

    PMID: 12742277BACKGROUND

  • 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.

    PMID: 1683918BACKGROUND

  • 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.

    PMID: 6193700BACKGROUND

  • 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.

    PMID: 3143285BACKGROUND

  • 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.

    PMID: 12748199BACKGROUND

  • 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.

    PMID: 8486007BACKGROUND

  • 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.

    PMID: 8191206BACKGROUND

  • 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.

    PMID: 16052417BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Salwa R. Demitry

    Assiut University

    STUDY DIRECTOR

  • Aliaë A. Mohamid

    Assiut University

    STUDY DIRECTOR

  • Ayman k. Hassan

    Assiut University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor

Study Record Dates

First Submitted

August 25, 2017

First Posted

August 30, 2017

Study Start

January 1, 2019

Primary Completion

December 31, 2020

Study Completion

January 1, 2021

Last Updated

April 8, 2021

Record last verified: 2021-04

Locations

EG(1)