<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03267667</url>
  </required_header>
  <id_info>
    <org_study_id>17100300</org_study_id>
    <nct_id>NCT03267667</nct_id>
  </id_info>
  <brief_title>Effect of OSA on RV Heamodynamics and Function</brief_title>
  <official_title>Effect of Obstructive Sleep Apnea on Right Ventricle Heamodynamics and Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Correlation of severity of obstructive sleep apnea and function of the right ventricle by&#xD;
      means of 2D echocardiography and cardiac MRI&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obstructive sleep apnea (OSA) is a frequently under diagnosed condition that has emerged as&#xD;
      an increasing medical problem with important social and financial implications worldwide. OSA&#xD;
      is a well established risk factor for systemic hypertension , myocardial infarction or&#xD;
      stroke.&#xD;
&#xD;
      Obstructive sleep apnea syndrome (OSAS) is characterized by repetitive collapse of the upper&#xD;
      airway during sleep .The obstructive apneic event is associated with considerable breathing&#xD;
      efforts against a totally or partially occluded upper airway, and apnea is terminated by an&#xD;
      arousal and heavy snoring as airflow is restored. Severity of OSAS is described according to&#xD;
      total number of apneas and hyperpneas per hour of sleep, which is named as the apnea-hypopnea&#xD;
      index (AHI).&#xD;
&#xD;
      Cardiovascular disturbances are the most serious complications of OSAS. These complications&#xD;
      include heart failure, acute myocardial infarction, nocturnal arrhythmias, stroke, systemic&#xD;
      and pulmonary hypertension. All these cardiovascular complications increase morbidity and&#xD;
      mortality of OSAS.&#xD;
&#xD;
      Currently, sleep apnea is accepted as one of the identifiable causes of hypertension. Also,&#xD;
      OSAS is closely associated with obesity and ageing.&#xD;
&#xD;
      There is conclusive evidence that OSAS influences right heart function (the&#xD;
      pathophysiological consequences of sleep apnea-hypopnea might result in an imbalance in&#xD;
      myocardial oxygen delivery/consumption ratio, activation of sympathetic and other&#xD;
      neurohormonal systems, and increased right and left ventricular after load )&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">January 1, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The RV function in subjects with OSA compared with healthy persons</measure>
    <time_frame>1 year</time_frame>
    <description>Assessment of RV function by cardiac MRI in OSA patients and healthy volunteers</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Early detection of any impairment in cardiac global function in the participants before causing symptoms.</measure>
    <time_frame>1 year</time_frame>
    <description>Cardiac MRI help to detect early cardiac dysfunction before symptoms appear which causes. Early detection equal early management which will improve the cardiac prognosis</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Sleep Apnea, Obstructive</condition>
  <arm_group>
    <arm_group_label>obstructive sleep apnea patients</arm_group_label>
    <description>number of 90 patients will be investigated by 2D echocardiography and cardiac MRI to determine the right ventricle function</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy volunteers</arm_group_label>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>2D Echocardiography and cardiac MRI</intervention_name>
    <description>imaging of right ventricle by both modalities to assess right ventricle function accurately</description>
    <arm_group_label>healthy volunteers</arm_group_label>
    <arm_group_label>obstructive sleep apnea patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study will include 90 patients who are diagnosed as obstructive sleep apnea by sleep&#xD;
        study and 10 healthy volunteers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects diagnosed as OSA with age range from 18 to 70 years&#xD;
&#xD;
          -  Glomerular filtration rate (MDRD formula-based) &gt; 60 ml/min&#xD;
&#xD;
          -  Arterial hypertension diagnosed according to the European Society of Hypertension 2013&#xD;
             Guidelines.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mental illness&#xD;
&#xD;
          -  Acute and chronic inflammation&#xD;
&#xD;
          -  Heart failure III or IV grade&#xD;
&#xD;
          -  Chronic administration of drugs with confirmed nephrotoxicity and/or&#xD;
             sympathicomimetics&#xD;
&#xD;
          -  Obstructive and restrictive pulmonary diseases which may deteriorate the function of&#xD;
             the respiratory system&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Salwa R. Demitry</last_name>
    <role>Study Director</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Aliaë A. Mohamid</last_name>
    <role>Study Director</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ayman k. Hassan</last_name>
    <role>Study Director</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assiut university</name>
      <address>
        <city>Assiut</city>
        <zip>71515</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <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. doi: 10.1001/jama.283.14.1829. Erratum In: JAMA 2002 Oct 23-30;288(16):1985.</citation>
    <PMID>10770144</PMID>
  </reference>
  <reference>
    <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. doi: 10.1056/NEJM200005113421901.</citation>
    <PMID>10805822</PMID>
  </reference>
  <reference>
    <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. doi: 10.1016/0140-6736(90)91799-g.</citation>
    <PMID>1973968</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>1630643</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>180875</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>12742277</PMID>
  </reference>
  <reference>
    <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. doi: 10.1016/0140-6736(91)92299-h.</citation>
    <PMID>1683918</PMID>
  </reference>
  <reference>
    <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. doi: 10.1016/0002-9149(83)90013-9.</citation>
    <PMID>6193700</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>3143285</PMID>
  </reference>
  <reference>
    <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. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14. Erratum In: JAMA. 2003 Jul 9;290(2):197.</citation>
    <PMID>12748199</PMID>
  </reference>
  <reference>
    <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. doi: 10.1378/chest.103.5.1336.</citation>
    <PMID>8486007</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>8191206</PMID>
  </reference>
  <reference>
    <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. doi: 10.1055/s-2005-864206.</citation>
    <PMID>16052417</PMID>
  </reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>April 5, 2021</last_update_submitted>
  <last_update_submitted_qc>April 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mary Zakher Bakhiet</investigator_full_name>
    <investigator_title>resident doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03267667
org study id: 17100300
nct id: NCT03267667
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Correlation of severity of obstructive sleep apnea and function of the right ventricle by
      means of 2D echocardiography and cardiac MRI
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 )
observational model: Case-Control
time perspective: Cross-Sectional
measure: The RV function in subjects with OSA compared with healthy persons
time frame: 1 year
description: Assessment of RV function by cardiac MRI in OSA patients and healthy volunteers
measure: Early detection of any impairment in cardiac global function in the participants before causing symptoms.
time frame: 1 year
description: Cardiac MRI help to detect early cardiac dysfunction before symptoms appear which causes. Early detection equal early management which will improve the cardiac prognosis
arm group label: obstructive sleep apnea patients
description: number of 90 patients will be investigated by 2D echocardiography and cardiac MRI to determine the right ventricle function
arm group label: healthy volunteers
description: 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
intervention type: Diagnostic Test
intervention name: 2D Echocardiography and cardiac MRI
description: imaging of right ventricle by both modalities to assess right ventricle function accurately
arm group label: healthy volunteers
arm group label: obstructive sleep apnea patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Salwa R. Demitry
role: Study Director
affiliation: Assiut University
last name: Aliaë A. Mohamid
role: Study Director
affiliation: Assiut University
last name: Ayman k. Hassan
role: Study Director
affiliation: Assiut University
facility: 
country: Egypt
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. doi: 10.1001/jama.283.14.1829. Erratum In: JAMA 2002 Oct 23-30;288(16):1985.
PMID: 10770144
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. doi: 10.1056/NEJM200005113421901.
PMID: 10805822
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. doi: 10.1016/0140-6736(90)91799-g.
PMID: 1973968
citation: 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: 1630643
citation: 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: 180875
citation: 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: 12742277
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. doi: 10.1016/0140-6736(91)92299-h.
PMID: 1683918
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. doi: 10.1016/0002-9149(83)90013-9.
PMID: 6193700
citation: 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: 3143285
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. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14. Erratum In: JAMA. 2003 Jul 9;290(2):197.
PMID: 12748199
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. doi: 10.1378/chest.103.5.1336.
PMID: 8486007
citation: 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: 8191206
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. doi: 10.1055/s-2005-864206.
PMID: 16052417
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mary Zakher Bakhiet
investigator title: resident doctor
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
sharing ipd: Undecided