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/NCT05981144</url>
    </required_header>
    <id_info>
      <org_study_id>4-2021-0921</org_study_id>
      <nct_id>NCT05981144</nct_id>
    </id_info>
    <brief_title>Exploration of Clonal Hematopoiesis of Indeterminate Potential in Non-ischemic Heart Failure With Reduced Ejection Fraction</brief_title>
    <official_title>Exploration of Clonal Hematopoiesis of Indeterminate Potential in Non-ischemic Heart Failure With Reduced Ejection Fraction</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Yonsei University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Yonsei 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>
        Clonal hematopoiesis of indeterminate potential (CHIP) refers to a phenomenon in which blood&#xD;
        cells with somatic mutation circulate in the peripheral blood due to abnormal proliferation&#xD;
        and differentiation of mutant hematopoietic cells.&#xD;
  &#xD;
        CHIP is considered one of the aging phenomena, and the mutant blood cells increased by CHIP&#xD;
        cause chronic inflammation, thereby increasing the occurrence of atherosclerotic&#xD;
        cardiovascular disease. Therefore, CHIP is known to be closely related to poor prognosis of&#xD;
        ischemic heart failure. Meanwhile, chronic inflammation may be involved in the development of&#xD;
        non-ischemic myocardial disease, which is one of the major causes of heart failure.&#xD;
  &#xD;
        This study will identify CHIP and perform NLRP3 inflammasome assay in 100 non-ischemic heart&#xD;
        failure patients and evaluate the relationship between CHIP and inflammation, imaging markers&#xD;
        of heart failure, Left ventricle reverse remodeling after guideline-directed medical&#xD;
        treatment, and prognosis of heart failure with reduced ejection fraction.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 23, 2021</start_date>
    <completion_date type="Actual">January 31, 2023</completion_date>
    <primary_completion_date type="Actual">January 31, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Left ventricular reverse remodeling</measure>
      <time_frame>3 months after guideline-directed medical treatment</time_frame>
      <description>a second measurement of left ventricular ejection fraction &gt; 40% and a ≥10% increase from baseline left ventricular ejection fraction of ≤ 40%</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Clinical outcome</measure>
      <time_frame>3 years after enrollment</time_frame>
      <description>Heart failure hospitalization or cardiovascular death</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">100</enrollment>
    <condition>Heart Failure With Reduced Ejection Fraction</condition>
    <arm_group>
      <arm_group_label>Experimental</arm_group_label>
      <description>Patients with heart failure without significant stenosis of the major epicardial coronary artery and reduced left ventricular ejection fraction below 40%</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Patients who need ACEI for cardiovascular disease&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. As an adult over the age of 19&#xD;
  &#xD;
            2. A history of left ventricular ejection fraction less than 40% on imaging tests within&#xD;
               3 years (HFrEF diagnosis),&#xD;
  &#xD;
            3. Have a cardiac MRI taken within 3 months of being diagnosed with HFrEF,&#xD;
  &#xD;
            4. A person who was diagnosed with non-ischemic left ventricular hypofunction heart&#xD;
               failure by performing coronary artery imaging (angiography, CT) at the time of&#xD;
               diagnosis of HFrEF&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with confirmed ischemic cardiomyopathy (when stenosis of 75% or more of major&#xD;
               coronary arteries is confirmed on coronary artery imaging or ischemic cardiomyopathy&#xD;
               findings such as transmural late gadolinium enhancement on cardiac MRI)&#xD;
  &#xD;
            2. History of solid cancer diagnosis and chemotherapy (drugs, radiation)&#xD;
  &#xD;
            3. History of blood cancer&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Chan Joo Lee</last_name>
      <role>Principal Investigator</role>
      <affiliation>Division of Cardiology, Severance Hospital, Yonsei University College of Medicine</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Severance hospital</name>
        <address>
          <city>Seoul</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Failure</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/NCT05981144
  org study id: 4-2021-0921
  nct id: NCT05981144
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Clonal hematopoiesis of indeterminate potential (CHIP) refers to a phenomenon in which blood
        cells with somatic mutation circulate in the peripheral blood due to abnormal proliferation
        and differentiation of mutant hematopoietic cells.
  
        CHIP is considered one of the aging phenomena, and the mutant blood cells increased by CHIP
        cause chronic inflammation, thereby increasing the occurrence of atherosclerotic
        cardiovascular disease. Therefore, CHIP is known to be closely related to poor prognosis of
        ischemic heart failure. Meanwhile, chronic inflammation may be involved in the development of
        non-ischemic myocardial disease, which is one of the major causes of heart failure.
  
        This study will identify CHIP and perform NLRP3 inflammasome assay in 100 non-ischemic heart
        failure patients and evaluate the relationship between CHIP and inflammation, imaging markers
        of heart failure, Left ventricle reverse remodeling after guideline-directed medical
        treatment, and prognosis of heart failure with reduced ejection fraction.
  observational model: Other
  time perspective: Prospective
  measure: Left ventricular reverse remodeling
  time frame: 3 months after guideline-directed medical treatment
  description: a second measurement of left ventricular ejection fraction > 40% and a ≥10% increase from baseline left ventricular ejection fraction of ≤ 40%
  measure: Clinical outcome
  time frame: 3 years after enrollment
  description: Heart failure hospitalization or cardiovascular death
  arm group label: Experimental
  description: Patients with heart failure without significant stenosis of the major epicardial coronary artery and reduced left ventricular ejection fraction below 40%
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Chan Joo Lee
  role: Principal Investigator
  affiliation: Division of Cardiology, Severance Hospital, Yonsei University College of Medicine
  facility: 
  country: Korea, Republic of
  responsible party type: Sponsor
  mesh term: Heart Failure
  sharing ipd: Undecided