<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/NCT03271385</url>
  </required_header>
  <id_info>
    <org_study_id>20170406J</org_study_id>
    <nct_id>NCT03271385</nct_id>
  </id_info>
  <brief_title>Differentiation HHD From HCM (EARLY-MYO-HHD)</brief_title>
  <official_title>EARLY Differentiation of MYOcardial Hypertrophy Between Hypertensive Heart Disease and Hypertrophic Cardiomyopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RenJi Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ruijin Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>LanZhou University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kunming Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Anzhen Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>West China Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>RenJi Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Differentiating hypertrophic cardiomyopathy (HCM) from hypertensive heart disease (HHD)&#xD;
      unavoidably encounters diagnostic challenges especially in patient of suspected HCM with&#xD;
      history of hypertension. Diverse and overlapping forms of HCM can often lead to ambiguity&#xD;
      when diagnosis is based on a single genetic or morphological index.&#xD;
&#xD;
      The investigators have deduced a integrated formula based on cardiac magnetic resonance (CMR)&#xD;
      imaging and established a differentiating flow-chart between HCM and HHD, the investigators&#xD;
      aim to identify their method in the current multi-center trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Both hypertrophic cardiomyopathy (HCM) and hypertensive heart disease (HHD) present left&#xD;
      ventricular hypertrophy (LVH), but the prognosis varies. Nevertheless, the feasibility of&#xD;
      distinguishing these two conditions is limited by the fact that overlapping LVH and diverse&#xD;
      forms of HCM can often lead to diagnostic ambiguity when diagnosis is based on a single&#xD;
      morphological index. Diagnosis is more difficult in a patient with a history of hypertension&#xD;
      and with left ventricular wall thickness between 11 and 15 mm. It also puzzles the situation&#xD;
      when hypertrophy without outflow-track obstruction was found in hypertensive subjects which&#xD;
      might not be explained solely by the history of hypertension.&#xD;
&#xD;
      The investigators have deduced an integrated formula based on cardiac magnetic resonance&#xD;
      (CMR) imaging and established a differentiating flow-chart between HCM and HHD. In this&#xD;
      study, the investigators aim to explore the applicability of the quantifying scheme for&#xD;
      distinguishing HCM from HHD in the multi-center trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>validation of the algorithm in all patients</measure>
    <time_frame>after post-procession and complete the flow chart within 24 hours</time_frame>
    <description>Evaluate the area under the curve of our algorithm compared with single parameter (wall thickness, strain) in all patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>validation of the algorithm in subgroup patients</measure>
    <time_frame>after post-procession and complete the flow chart within 24 hours</time_frame>
    <description>Evaluate the area under the curve of our algorithm compared with single parameter (wall thickness, strain) in subgroup patients (HHD and HCM/HBP-; HHD and HCM/HBP+; HHD and HCM/OBSR-; HHD and HCM/HBP+/OBSR-)</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">465</enrollment>
  <condition>Hypertrophic Cardiomyopathy</condition>
  <condition>Hypertensive Heart Disease</condition>
  <arm_group>
    <arm_group_label>hypertrophic cardiomyopathy group</arm_group_label>
    <description>The hypertrophic cardiomyopathy was diagnosed by left ventricular hypertrophy via echocardiography (wall thickness &gt;15 mm) with either genetic determination of a pathogenic mutation or ) left ventricular hypertrophy (LVH) (end-diastolic wall thickness &gt;15 mm) with resting left ventricular outflow tract obstruction or hypertrophy in a recognisable pattern, i.e., ventricular bulge in apical-variant HCM. And then patients with hypertrophic cardiomyopathy were evaluated by the predetermined differentiating formula.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>hypertensive heart disease group</arm_group_label>
    <description>The diagnosis of hypertensive heart disease was based on medical history and conventional echocardiography. Long durations of uncontrolled hypertension for at least 5 years with systolic blood pressure [BP] ≥150 mm Hg or diastolic BP ≥90 mm Hg or both in the absence of other cardiac or systemic diseases were used as criteria. And then patients with hypertensive heart disease were evaluated by the predetermined differentiating formula.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <description>The healthy age-matched controls were generally volunteers with a normal electrocardiogram, normal echocardiographic examination, and overall normal CMR findings. And then patients with normal findings were were evaluated by the predetermined differentiating formula.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>evaluated by the predetermined differentiating formula</intervention_name>
    <description>After recruiting patients, collecting the baseline data, a CMR scan will be carried out and post-processed, a predetermined differentiating formula (including left ventricular morphology, ejection fraction, presence of late gadolinium enhancement, T1 value and strain data) will be used to produce a cardiac values, which is to be input into our differentiating flow.</description>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>hypertensive heart disease group</arm_group_label>
    <arm_group_label>hypertrophic cardiomyopathy group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive subjects were prospectively enrolled into 3 cohorts between July 2017 and June&#xD;
        2020. The cohorts were divided as follows: the hypertrophic cardiomyopathy, hypertensive&#xD;
        heart disease and control groups&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Control group: (1) Absence of known systemic diseases; (2)Normal examinations（normal&#xD;
             findings in both echocardiography and CMR）.&#xD;
&#xD;
          2. Hypertrophic cardiomyopathy: 1) genetic determination of a pathogenic mutation or 2)&#xD;
             left ventricular hypertrophy (LVH) (end-diastolic wall thickness &gt;15 mm) with resting&#xD;
             left ventricular outflow tract obstruction or 3) hypertrophy in a recognizable&#xD;
             pattern, i.e., ventricular bulge in apical-variant HCM; Of note, patients with&#xD;
             documented HCM were divided into subgroups based on whether concomitant with&#xD;
             hypertension or left ventricular outflow tract (LVOT) obstruction.&#xD;
&#xD;
          3. Hypertensive Heart Disease: (1) Long durations of uncontrolled hypertension (systolic&#xD;
             blood pressure≥150 mm Hg or diastolic blood pressure ≥90 mm Hg); Echocardiography:&#xD;
             left ventricular wall thickness in diastolic &gt;11mm; Absence of other cardiac or&#xD;
             systemic diseases; (2) left ventricular mass/body surface area &gt;115 g/m2 (Male) or &gt;95&#xD;
             g/m2 (Female).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Documented coronary artery disease: previous history or CAG&gt;50%;&#xD;
&#xD;
          2. NYHA Ⅳ level;&#xD;
&#xD;
          3. Severe aortic valve stenosis;&#xD;
&#xD;
          4. Standard metallic contraindications to CMR;&#xD;
&#xD;
          5. Systemic diseases or Infiltrative cardiomyopathy;&#xD;
&#xD;
          6. Septal ablation for drug-refractory hypertrophic obstructive cardiomyopathy.&#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>Meng Jiang, MD</last_name>
    <role>Study Chair</role>
    <affiliation>RenJi Hospital, School of Medicine, Shanghai Jiaotong University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lianming Wu, MD</last_name>
    <role>Study Director</role>
    <affiliation>RenJi Hospital, School of Medicine, Shanghai Jiaotong University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Renji Hospital</name>
      <address>
        <city>Shanghai</city>
        <zip>200127</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>November 14, 2022</last_update_submitted>
  <last_update_submitted_qc>November 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hypertrophic Cardiomyopathy</keyword>
  <keyword>hypertensive Heart Disease</keyword>
  <keyword>cardiac magnetic resonance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Cardiomyopathies</mesh_term>
    <mesh_term>Cardiomyopathy, Hypertrophic</mesh_term>
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Hypertrophy</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/NCT03271385
org study id: 20170406J
nct id: NCT03271385
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Differentiating hypertrophic cardiomyopathy (HCM) from hypertensive heart disease (HHD)
      unavoidably encounters diagnostic challenges especially in patient of suspected HCM with
      history of hypertension. Diverse and overlapping forms of HCM can often lead to ambiguity
      when diagnosis is based on a single genetic or morphological index.

      The investigators have deduced a integrated formula based on cardiac magnetic resonance (CMR)
      imaging and established a differentiating flow-chart between HCM and HHD, the investigators
      aim to identify their method in the current multi-center trial.
Both hypertrophic cardiomyopathy (HCM) and hypertensive heart disease (HHD) present left
      ventricular hypertrophy (LVH), but the prognosis varies. Nevertheless, the feasibility of
      distinguishing these two conditions is limited by the fact that overlapping LVH and diverse
      forms of HCM can often lead to diagnostic ambiguity when diagnosis is based on a single
      morphological index. Diagnosis is more difficult in a patient with a history of hypertension
      and with left ventricular wall thickness between 11 and 15 mm. It also puzzles the situation
      when hypertrophy without outflow-track obstruction was found in hypertensive subjects which
      might not be explained solely by the history of hypertension.

      The investigators have deduced an integrated formula based on cardiac magnetic resonance
      (CMR) imaging and established a differentiating flow-chart between HCM and HHD. In this
      study, the investigators aim to explore the applicability of the quantifying scheme for
      distinguishing HCM from HHD in the multi-center trial.
observational model: Case-Control
time perspective: Prospective
measure: validation of the algorithm in all patients
time frame: after post-procession and complete the flow chart within 24 hours
description: Evaluate the area under the curve of our algorithm compared with single parameter (wall thickness, strain) in all patients
measure: validation of the algorithm in subgroup patients
time frame: after post-procession and complete the flow chart within 24 hours
description: Evaluate the area under the curve of our algorithm compared with single parameter (wall thickness, strain) in subgroup patients (HHD and HCM/HBP-; HHD and HCM/HBP+; HHD and HCM/OBSR-; HHD and HCM/HBP+/OBSR-)
arm group label: hypertrophic cardiomyopathy group
description: The hypertrophic cardiomyopathy was diagnosed by left ventricular hypertrophy via echocardiography (wall thickness >15 mm) with either genetic determination of a pathogenic mutation or ) left ventricular hypertrophy (LVH) (end-diastolic wall thickness >15 mm) with resting left ventricular outflow tract obstruction or hypertrophy in a recognisable pattern, i.e., ventricular bulge in apical-variant HCM. And then patients with hypertrophic cardiomyopathy were evaluated by the predetermined differentiating formula.
arm group label: hypertensive heart disease group
description: The diagnosis of hypertensive heart disease was based on medical history and conventional echocardiography. Long durations of uncontrolled hypertension for at least 5 years with systolic blood pressure [BP] ≥150 mm Hg or diastolic BP ≥90 mm Hg or both in the absence of other cardiac or systemic diseases were used as criteria. And then patients with hypertensive heart disease were evaluated by the predetermined differentiating formula.
arm group label: control group
description: The healthy age-matched controls were generally volunteers with a normal electrocardiogram, normal echocardiographic examination, and overall normal CMR findings. And then patients with normal findings were were evaluated by the predetermined differentiating formula.
intervention type: Diagnostic Test
intervention name: evaluated by the predetermined differentiating formula
description: After recruiting patients, collecting the baseline data, a CMR scan will be carried out and post-processed, a predetermined differentiating formula (including left ventricular morphology, ejection fraction, presence of late gadolinium enhancement, T1 value and strain data) will be used to produce a cardiac values, which is to be input into our differentiating flow.
arm group label: control group
arm group label: hypertensive heart disease group
arm group label: hypertrophic cardiomyopathy group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Meng Jiang, MD
role: Study Chair
affiliation: RenJi Hospital, School of Medicine, Shanghai Jiaotong University
last name: Lianming Wu, MD
role: Study Director
affiliation: RenJi Hospital, School of Medicine, Shanghai Jiaotong University
facility: 
country: China
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Cardiomyopathies
mesh term: Cardiomyopathy, Hypertrophic
mesh term: Hypertension
mesh term: Hypertrophy
sharing ipd: No