<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/NCT04402268</url>
  </required_header>
  <id_info>
    <org_study_id>PoznanUMP</org_study_id>
    <nct_id>NCT04402268</nct_id>
  </id_info>
  <brief_title>Efficacy of Risk Assessment for Sudden Cardiac Death in Patients With Hypertrophic Cardiomyopathy</brief_title>
  <official_title>Efficacy of Risk Assessment for Sudden Cardiac Death in Patients With Hypertrophic Cardiomyopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Poznan University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Poznan University of Medical Sciences</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypertrophic cardiomyopathy (HCM) is a heart disease characterized by hypertrophy of the left&#xD;
      ventricular myocardium and is most often caused by mutations in sarcomere genes. The&#xD;
      structural and functional abnormalities cannot be explained by flow-limiting coronary artery&#xD;
      disease or loading conditions. The disease affects at least 0,2% of the population worldwide&#xD;
      and is the most common cause of sudden cardiac death (SCD) in young people and competitive&#xD;
      athletes due to fatal ventricular arrhythmia, but in most patients, however, HCM has a benign&#xD;
      course. Therefore, it is of utmost importance to properly evaluate patients and identify&#xD;
      those who would benefit from a cardioverter-defibrillator (ICD) implantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypertrophic cardiomyopathy (HCM) is a heart disease characterized by hypertrophy of the left&#xD;
      ventricular myocardium and is most often caused by mutations in sarcomere genes. The&#xD;
      structural and functional abnormalities cannot be explained by flow-limiting coronary artery&#xD;
      disease or loading conditions. The disease affects at least 0,2% of the population worldwide&#xD;
      and is the most common cause of sudden cardiac death (SCD) in young people and competitive&#xD;
      athletes due to fatal ventricular arrhythmia, but in most patients, however, HCM has a benign&#xD;
      course. Therefore, it is of utmost importance to properly evaluate patients and identify&#xD;
      those who would benefit from a cardioverter-defibrillator (ICD) implantation.&#xD;
&#xD;
      This study assesses the accuracy of the HCM SCD-Risk Calculator, recommended by European&#xD;
      Society of Cardiology guidelines, in patients treated in the Ist Department of Cardiology of&#xD;
      Poznan University of Medical Sciences from 2005 to 2018.&#xD;
&#xD;
      The study group consisted of 252 patients aged 20-88 (mean 53,8 ± 15,1, median 54); 49,6%&#xD;
      were men. The protocol consisted of medical history collection (including a questionnaire),&#xD;
      physical examination and additional tests such as echocardiography with the assessment of&#xD;
      global longitudinal strain and average strain, cardiac magnetic resonance, ambulatory ECG&#xD;
      monitoring, control of implantable devices and exercise testing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2014</start_date>
  <completion_date type="Actual">February 28, 2019</completion_date>
  <primary_completion_date type="Actual">September 1, 2018</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>Sudden cardiac death (SCD) in risk groups</measure>
    <time_frame>2005-2018</time_frame>
    <description>Number of SCD cases in each of risk groups according to HCM Risk-SCD Calculator</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>New risk factors of sudden cardiac death (SCD)</measure>
    <time_frame>2005-2018</time_frame>
    <description>New echocardiographic features, such as glibal longitudinal strain, average strain, left atrial volume index, which allow to better estimate the risk of SCD</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">252</enrollment>
  <condition>Hypertrophic Cardiomyopathy</condition>
  <arm_group>
    <arm_group_label>Low risk</arm_group_label>
    <description>Low risk of sudden cardiac death according to HCM Risk-SCD Calculator</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intermediate risk</arm_group_label>
    <description>Intermediate risk of sudden cardiac death according to HCM Risk-SCD Calculator</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High risk</arm_group_label>
    <description>High risk of sudden cardiac death according to HCM Risk-SCD Calculator</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cardioverter-defibrillator</intervention_name>
    <description>We analyzed how many HCM patients reached an end-point of sudden cardiac death defined as adequate intervention of cardioverter-defibrillator or sudden cardiac arrest.</description>
    <arm_group_label>High risk</arm_group_label>
    <arm_group_label>Intermediate risk</arm_group_label>
    <arm_group_label>Low risk</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study group consisted of 252 patients with hypertrophic cardiomyopathy aged 20-88 (mean&#xD;
        53,8 ± 15,1, median 54); 49,6% were men.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Hypertrophic cardiomyopathy,&#xD;
&#xD;
          2. Minimum 18 years,&#xD;
&#xD;
          3. Questionnaire,&#xD;
&#xD;
          4. Assessment of HCM SCD-Risk Calculator at the beginning of the observation,&#xD;
&#xD;
          5. Regular visits in Cardiology Outpatient Clinic,&#xD;
&#xD;
          6. Agreement to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Poorly controlled hypertension (systolic pressure on the next two visits in the&#xD;
             Cardiology Outpatient Clinic &gt;180 mmHg),&#xD;
&#xD;
          2. Haemodynamically significant valvular heart disease or valve replacement condition,&#xD;
&#xD;
          3. Past myocardial infarction (haemodynamically significant changes found in&#xD;
             coronarography),&#xD;
&#xD;
          4. Heart transplant,&#xD;
&#xD;
          5. Insufficient amount of data from the subject and additional tests allowing for further&#xD;
             analysis,&#xD;
&#xD;
          6. Lack of consent to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Poznan Univeristy of Medical Sciences</name>
      <address>
        <city>Poznań</city>
        <state>Wielkopolska</state>
        <zip>61-848</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>May 22, 2020</last_update_submitted>
  <last_update_submitted_qc>May 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Poznan University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Daria Adamczak</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>sudden cardiac death</keyword>
  <keyword>risk assesment</keyword>
  <keyword>HCM Risk-SCD Calculator</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiomyopathies</mesh_term>
    <mesh_term>Cardiomyopathy, Hypertrophic</mesh_term>
    <mesh_term>Death, Sudden, Cardiac</mesh_term>
    <mesh_term>Death</mesh_term>
    <mesh_term>Hypertrophy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Not possible due to Polish law regulations.</ipd_description>
  </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/NCT04402268
org study id: PoznanUMP
nct id: NCT04402268
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Hypertrophic cardiomyopathy (HCM) is a heart disease characterized by hypertrophy of the left
      ventricular myocardium and is most often caused by mutations in sarcomere genes. The
      structural and functional abnormalities cannot be explained by flow-limiting coronary artery
      disease or loading conditions. The disease affects at least 0,2% of the population worldwide
      and is the most common cause of sudden cardiac death (SCD) in young people and competitive
      athletes due to fatal ventricular arrhythmia, but in most patients, however, HCM has a benign
      course. Therefore, it is of utmost importance to properly evaluate patients and identify
      those who would benefit from a cardioverter-defibrillator (ICD) implantation.
Hypertrophic cardiomyopathy (HCM) is a heart disease characterized by hypertrophy of the left
      ventricular myocardium and is most often caused by mutations in sarcomere genes. The
      structural and functional abnormalities cannot be explained by flow-limiting coronary artery
      disease or loading conditions. The disease affects at least 0,2% of the population worldwide
      and is the most common cause of sudden cardiac death (SCD) in young people and competitive
      athletes due to fatal ventricular arrhythmia, but in most patients, however, HCM has a benign
      course. Therefore, it is of utmost importance to properly evaluate patients and identify
      those who would benefit from a cardioverter-defibrillator (ICD) implantation.

      This study assesses the accuracy of the HCM SCD-Risk Calculator, recommended by European
      Society of Cardiology guidelines, in patients treated in the Ist Department of Cardiology of
      Poznan University of Medical Sciences from 2005 to 2018.

      The study group consisted of 252 patients aged 20-88 (mean 53,8 ± 15,1, median 54); 49,6%
      were men. The protocol consisted of medical history collection (including a questionnaire),
      physical examination and additional tests such as echocardiography with the assessment of
      global longitudinal strain and average strain, cardiac magnetic resonance, ambulatory ECG
      monitoring, control of implantable devices and exercise testing.
observational model: Cohort
time perspective: Retrospective
measure: Sudden cardiac death (SCD) in risk groups
time frame: 2005-2018
description: Number of SCD cases in each of risk groups according to HCM Risk-SCD Calculator
measure: New risk factors of sudden cardiac death (SCD)
time frame: 2005-2018
description: New echocardiographic features, such as glibal longitudinal strain, average strain, left atrial volume index, which allow to better estimate the risk of SCD
arm group label: Low risk
description: Low risk of sudden cardiac death according to HCM Risk-SCD Calculator
arm group label: Intermediate risk
description: Intermediate risk of sudden cardiac death according to HCM Risk-SCD Calculator
arm group label: High risk
description: High risk of sudden cardiac death according to HCM Risk-SCD Calculator
intervention type: Device
intervention name: Cardioverter-defibrillator
description: We analyzed how many HCM patients reached an end-point of sudden cardiac death defined as adequate intervention of cardioverter-defibrillator or sudden cardiac arrest.
arm group label: High risk
arm group label: Intermediate risk
arm group label: Low risk
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Poznan University of Medical Sciences
investigator full name: Daria Adamczak
investigator title: MD
mesh term: Cardiomyopathies
mesh term: Cardiomyopathy, Hypertrophic
mesh term: Death, Sudden, Cardiac
mesh term: Death
mesh term: Hypertrophy
sharing ipd: No
ipd description: Not possible due to Polish law regulations.