<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/NCT04505449</url>
  </required_header>
  <id_info>
    <org_study_id>LHCR</org_study_id>
    <nct_id>NCT04505449</nct_id>
  </id_info>
  <brief_title>Invasive Left Heart Catheterization Registry</brief_title>
  <official_title>Role of Invasive Left Heart Catheterization for Patients Suspected Heart Failure With Preserved Ejection Fraction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</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>
      Retrospectively enrolled suspicious of heart failure with preserved ejection fraction (HFpEF)&#xD;
      patients who underwent left heart catheterization with the measurement of left ventricular&#xD;
      end-diastolic pressure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Heart failure (HF) with preserved ejection fraction (HFpEF) remains a poorly understood&#xD;
      clinical syndrome without effective targeted therapies. The clinical syndrome of HFpEF&#xD;
      develops from a complex interaction of several risk factors such as aging, obesity,&#xD;
      hypertension, myocardial ischemia, and arterial stiffness that cause organ dysfunction and,&#xD;
      ultimately, clinical symptoms. Although the H2FPEF and HFA-PEFF scores have recently been&#xD;
      proposed to estimate the probability of HFpEF in patients suffering from unexplained dyspnea,&#xD;
      diagnosing HFpEF remains still challenging. The aim of the current registry was to evaluate&#xD;
      the role of invasive left heart catheterization with the measurement of left ventricular&#xD;
      end-diastolic pressure (LVEDP) in suspicious of HFpEF patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 13, 2019</start_date>
  <completion_date type="Actual">March 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 12, 2020</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rates of Death or re-hospitalization due to heart failure</measure>
    <time_frame>10 Years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rates of All-cause death</measure>
    <time_frame>10 Years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of Re-hospitalization due to heart failure</measure>
    <time_frame>10 Years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of Myocardial infarction</measure>
    <time_frame>10 Years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of Stroke</measure>
    <time_frame>10 Years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">404</enrollment>
  <condition>Heart Failure With Preserved Ejection Fraction</condition>
  <condition>Left Ventricular Diastolic Dysfunction</condition>
  <arm_group>
    <arm_group_label>Left heart catheterization</arm_group_label>
    <description>Symptomatic patients who underwent left heart catheterization and coronary angiography.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Left heart catheterization</intervention_name>
    <description>Patients who underwent left heart catheterization</description>
    <arm_group_label>Left heart catheterization</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Retrospectively enrolled symptomatic patients who underwent left heart catheterization&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Left ventricular ejection fraction &gt; 50%&#xD;
&#xD;
          -  Patients who had a symptom and/or signs of heart failure (dyspnea on exertion, chest&#xD;
             discomfort, fatigue, dizziness, or ankle edema)&#xD;
&#xD;
          -  Patients who underwent left heart catheterization with the measurement of left&#xD;
             ventricular end-diastolic pressure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Left ventricular ejection fraction &lt;50%&#xD;
&#xD;
          -  Acute coronary syndrome&#xD;
&#xD;
          -  More than moderate valvular heart disease&#xD;
&#xD;
          -  Primary cardiomyopathies such as dilated cardiomyopathy and hypertrophic&#xD;
             cardiomyopathy, amyloidosis&#xD;
&#xD;
          -  Pulmonary arterial hypertension&#xD;
&#xD;
          -  Heart transplantation&#xD;
&#xD;
          -  Constrictive pericarditis&#xD;
&#xD;
          -  Stress-induced cardiomyopathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeong Hoon Yang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Samsung Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>August 6, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>October 25, 2022</last_update_submitted>
  <last_update_submitted_qc>October 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
    <investigator_full_name>Jeong Hoon Yang</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Heart failure with preserved ejection fraction</keyword>
  <keyword>Left ventricular end diastolic pressure</keyword>
  <keyword>Echocardiography</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>No</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/NCT04505449
org study id: LHCR
nct id: NCT04505449
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Retrospectively enrolled suspicious of heart failure with preserved ejection fraction (HFpEF)
      patients who underwent left heart catheterization with the measurement of left ventricular
      end-diastolic pressure.
Heart failure (HF) with preserved ejection fraction (HFpEF) remains a poorly understood
      clinical syndrome without effective targeted therapies. The clinical syndrome of HFpEF
      develops from a complex interaction of several risk factors such as aging, obesity,
      hypertension, myocardial ischemia, and arterial stiffness that cause organ dysfunction and,
      ultimately, clinical symptoms. Although the H2FPEF and HFA-PEFF scores have recently been
      proposed to estimate the probability of HFpEF in patients suffering from unexplained dyspnea,
      diagnosing HFpEF remains still challenging. The aim of the current registry was to evaluate
      the role of invasive left heart catheterization with the measurement of left ventricular
      end-diastolic pressure (LVEDP) in suspicious of HFpEF patients.
observational model: Cohort
time perspective: Retrospective
measure: Rates of Death or re-hospitalization due to heart failure
time frame: 10 Years
measure: Rates of All-cause death
time frame: 10 Years
measure: Rates of Re-hospitalization due to heart failure
time frame: 10 Years
measure: Rates of Myocardial infarction
time frame: 10 Years
measure: Rates of Stroke
time frame: 10 Years
arm group label: Left heart catheterization
description: Symptomatic patients who underwent left heart catheterization and coronary angiography.
intervention type: Diagnostic Test
intervention name: Left heart catheterization
description: Patients who underwent left heart catheterization
arm group label: Left heart catheterization
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Jeong Hoon Yang, MD
role: Principal Investigator
affiliation: Samsung Medical Center
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Samsung Medical Center
investigator full name: Jeong Hoon Yang
investigator title: Professor
mesh term: Heart Failure
mesh term: Ventricular Dysfunction, Left
sharing ipd: No