xml: <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/NCT05972356</url>
    </required_header>
    <id_info>
      <org_study_id>W23_003#23.024</org_study_id>
      <nct_id>NCT05972356</nct_id>
    </id_info>
    <brief_title>Effect of Left Ventricle Diastolic Dysfunction on Outcomes in Female Cardiac Surgery Patients</brief_title>
    <acronym>EDISON</acronym>
    <official_title>The Effect of Left Ventricular DIastolic Dysfunction on Short Term Cardiac Surgery Outcomes in Female Cardiac patieNts</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</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>
        The aim of this study is to evaluate the differences between males and females with LVDD,&#xD;
        undergoing cardiac surgery. We will look at perioperative factors such as body weight, body&#xD;
        surface area, previous medical history, cardiac function measured by amongst others,&#xD;
        transoesophageal echocardiography and haemodynamic parameters, transfusion, coagulation,&#xD;
        cardiopulmonary bypass (CPB) related factors, inotropic requirements, risk, and outcome&#xD;
        scores as well as complications, morbidity and mortality at 30 days. We will evaluate these&#xD;
        variables in an observational setting, with the goal of improving outcome in females after&#xD;
        cardiac surgery in the future.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Cardiovascular disease is the leading cause of death among females in the Netherlands.&#xD;
        According to the Netherlands Heart Registry (NHR), 25% more females than males died as a&#xD;
        result of cardiovascular disease in 2019. In addition, females who undergo a cardiac surgery&#xD;
        intervention have a higher risk of morbidity and mortality after cardiac surgery than males.1&#xD;
  &#xD;
        An important predictor and risk factor of adverse outcomes after cardiac surgery is the&#xD;
        perioperative presence of heart failure (HF) with preserved ejection fraction (EF) (HFpEF).&#xD;
  &#xD;
        HFpEF, also known as left ventricular diastolic dysfunction (LVDD), accounts for 30-50% of&#xD;
        all patients presenting with symptoms of HF.2 Two-thirds of these patients are female.3 The&#xD;
        incidence of LVDD is generally increases with age.4 However, females are more likely to&#xD;
        develop LVDD than males of the same age (ratio 2:1).5 Vascular stiffening is a crucial&#xD;
        pathophysiological factor that contributes to the higher prevalence of LVDD in females.&#xD;
        Females show a faster decline of ventricular elastance with age compared with males.6&#xD;
        Furthermore, several comorbidities contribute to a higher prevalence of LVDD in females: iron&#xD;
        deficiency, diabetes, obesity, hypertension, preeclampsia, and autoimmune diseases. All are&#xD;
        associated with the onset of an inflammatory response, which is considered as an important&#xD;
        factor in the development of LVDD.6&#xD;
  &#xD;
        In diagnosing LVDD and determining its severity, echocardiography is of crucial value.&#xD;
        Indeed, echocardiographic imaging allows LVDD to be classified into grades ranging from grade&#xD;
        I (mild) to grade III (severe). In this regard, a higher grade is equivalent to a higher&#xD;
        likelihood of symptomatic HF, and a worse prognosis. Transoesophageal echocardiography is the&#xD;
        standard-of-care perioperative diagnostic intervention during cardiac surgery operations, to&#xD;
        assess cardiac function. Intraoperatively, the simplified algorithm of Swaminathan et al.,8&#xD;
        is used to assess diastolic function.&#xD;
  &#xD;
        Several studies investigated sex-related differences in the outcomes of patients with LVDD,&#xD;
        who were treated conservatively. 9-12 These studies demonstrated that females with LVDD had&#xD;
        similar outcomes of in-hospital and all-cause mortality compared with males. However, none of&#xD;
        these studies focused on outcomes after cardiac surgery.&#xD;
  &#xD;
        Additionally - despite known differences leading to higher morbidity and mortality in females&#xD;
        after cardiac surgery - basic and clinical research has predominantly included male animals&#xD;
        and male patients.&#xD;
  &#xD;
        The aim of this study is to evaluate the differences between males and females with LVDD,&#xD;
        undergoing cardiac surgery. We will look at perioperative factors such as body weight, body&#xD;
        surface area, previous medical history, cardiac function measured by amongst others,&#xD;
        transoesophageal echocardiography and haemodynamic parameters, transfusion, coagulation,&#xD;
        cardiopulmonary bypass (CPB) related factors, inotropic requirements, risk, and outcome&#xD;
        scores as well as complications, morbidity and mortality at 30 days. We will evaluate these&#xD;
        variables in an observational setting, with the goal of improving outcome in females after&#xD;
        cardiac surgery in the future.&#xD;
  &#xD;
        We hypothesise that LVDD is more pronounced in female patients compared to male patients.&#xD;
        Additionally, we hypothesise that females with LVDD (dependent on the grade of LVDD) have a&#xD;
        poorer early outcome (≤30 days) after cardiac surgery than male patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 25, 2023</start_date>
    <completion_date type="Anticipated">July 25, 2027</completion_date>
    <primary_completion_date type="Anticipated">July 25, 2026</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Left ventricular diastolic dysfunction</measure>
      <time_frame>Before statrt bypass and end of bypass</time_frame>
      <description>number of patients with LVDD (grade I - III) before and after CPB. LVDD is measured by using the ratio of trans-mitral early flow velocity to early mitral annular tissue velocity (E/E')</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Composite endpoint</measure>
      <time_frame>measured 30 days after surgery</time_frame>
      <description>Composite endpoint: Mortality,Cerebrovascular accident (CVA), with persistent neurological disability, Acute kidney injury (AKI), as defined by KDIGO 2012,Low cardiac output syndrome (LCOS) with a vasoactive-inotropic score (VIS) &gt; 45 or need for cardiac assist device,Pulmonary (and other) complications requiring ventilation &gt;48 hours</description>
    </secondary_outcome>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Left Sided Heart Failure</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Adult patients undergoing cardiac surgery will be asked for permission to use data&#xD;
          collected as standard-of-care&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patients &gt;18 years, who undergo cardiac surgery from 1 January 2023 till 31&#xD;
               December 2026 in the Amsterdam UMC&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who object to the re-use of their care data&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Markus W Hollmann, Prof.Dr.Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jennifer Breel, MSc</last_name>
      <phone>+31(0)20 2566 2533</phone>
      <email>j.s.breel@amsterdamumc.nl</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Susanne Eberl, MD,PhD</last_name>
      <email>s.eberl@amsterdamumc.nl</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
      <investigator_full_name>Jennifer Breel</investigator_full_name>
      <investigator_title>drs.</investigator_title>
    </responsible_party>
    <keyword>sex-differences</keyword>
    <keyword>left ventricular diastolic dysfunction</keyword>
    <keyword>cardiac surgery</keyword>
    <keyword>outcomes</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Failure</mesh_term>
      <mesh_term>Ventricular Dysfunction, Left</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05972356
  org study id: W23_003#23.024
  nct id: NCT05972356
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to evaluate the differences between males and females with LVDD,
        undergoing cardiac surgery. We will look at perioperative factors such as body weight, body
        surface area, previous medical history, cardiac function measured by amongst others,
        transoesophageal echocardiography and haemodynamic parameters, transfusion, coagulation,
        cardiopulmonary bypass (CPB) related factors, inotropic requirements, risk, and outcome
        scores as well as complications, morbidity and mortality at 30 days. We will evaluate these
        variables in an observational setting, with the goal of improving outcome in females after
        cardiac surgery in the future.
  Cardiovascular disease is the leading cause of death among females in the Netherlands.
        According to the Netherlands Heart Registry (NHR), 25% more females than males died as a
        result of cardiovascular disease in 2019. In addition, females who undergo a cardiac surgery
        intervention have a higher risk of morbidity and mortality after cardiac surgery than males.1
  
        An important predictor and risk factor of adverse outcomes after cardiac surgery is the
        perioperative presence of heart failure (HF) with preserved ejection fraction (EF) (HFpEF).
  
        HFpEF, also known as left ventricular diastolic dysfunction (LVDD), accounts for 30-50% of
        all patients presenting with symptoms of HF.2 Two-thirds of these patients are female.3 The
        incidence of LVDD is generally increases with age.4 However, females are more likely to
        develop LVDD than males of the same age (ratio 2:1).5 Vascular stiffening is a crucial
        pathophysiological factor that contributes to the higher prevalence of LVDD in females.
        Females show a faster decline of ventricular elastance with age compared with males.6
        Furthermore, several comorbidities contribute to a higher prevalence of LVDD in females: iron
        deficiency, diabetes, obesity, hypertension, preeclampsia, and autoimmune diseases. All are
        associated with the onset of an inflammatory response, which is considered as an important
        factor in the development of LVDD.6
  
        In diagnosing LVDD and determining its severity, echocardiography is of crucial value.
        Indeed, echocardiographic imaging allows LVDD to be classified into grades ranging from grade
        I (mild) to grade III (severe). In this regard, a higher grade is equivalent to a higher
        likelihood of symptomatic HF, and a worse prognosis. Transoesophageal echocardiography is the
        standard-of-care perioperative diagnostic intervention during cardiac surgery operations, to
        assess cardiac function. Intraoperatively, the simplified algorithm of Swaminathan et al.,8
        is used to assess diastolic function.
  
        Several studies investigated sex-related differences in the outcomes of patients with LVDD,
        who were treated conservatively. 9-12 These studies demonstrated that females with LVDD had
        similar outcomes of in-hospital and all-cause mortality compared with males. However, none of
        these studies focused on outcomes after cardiac surgery.
  
        Additionally - despite known differences leading to higher morbidity and mortality in females
        after cardiac surgery - basic and clinical research has predominantly included male animals
        and male patients.
  
        The aim of this study is to evaluate the differences between males and females with LVDD,
        undergoing cardiac surgery. We will look at perioperative factors such as body weight, body
        surface area, previous medical history, cardiac function measured by amongst others,
        transoesophageal echocardiography and haemodynamic parameters, transfusion, coagulation,
        cardiopulmonary bypass (CPB) related factors, inotropic requirements, risk, and outcome
        scores as well as complications, morbidity and mortality at 30 days. We will evaluate these
        variables in an observational setting, with the goal of improving outcome in females after
        cardiac surgery in the future.
  
        We hypothesise that LVDD is more pronounced in female patients compared to male patients.
        Additionally, we hypothesise that females with LVDD (dependent on the grade of LVDD) have a
        poorer early outcome (≤30 days) after cardiac surgery than male patients.
  observational model: Cohort
  time perspective: Prospective
  measure: Left ventricular diastolic dysfunction
  time frame: Before statrt bypass and end of bypass
  description: number of patients with LVDD (grade I - III) before and after CPB. LVDD is measured by using the ratio of trans-mitral early flow velocity to early mitral annular tissue velocity (E/E')
  measure: Composite endpoint
  time frame: measured 30 days after surgery
  description: Composite endpoint: Mortality,Cerebrovascular accident (CVA), with persistent neurological disability, Acute kidney injury (AKI), as defined by KDIGO 2012,Low cardiac output syndrome (LCOS) with a vasoactive-inotropic score (VIS) > 45 or need for cardiac assist device,Pulmonary (and other) complications requiring ventilation >48 hours
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Markus W Hollmann, Prof.Dr.Dr.
  role: Principal Investigator
  affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  last name: Jennifer Breel, MSc
  phone: +31(0)20 2566 2533
  email: j.s.breel@amsterdamumc.nl
  last name: Susanne Eberl, MD,PhD
  email: s.eberl@amsterdamumc.nl
  responsible party type: Principal Investigator
  investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  investigator full name: Jennifer Breel
  investigator title: drs.
  mesh term: Heart Failure
  mesh term: Ventricular Dysfunction, Left
  sharing ipd: Undecided