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/NCT06023186</url>
    </required_header>
    <id_info>
      <org_study_id>HSR220293</org_study_id>
      <nct_id>NCT06023186</nct_id>
    </id_info>
    <brief_title>Effect of Mavacamten Treatment on Coronary Flow Reserve in oHCM</brief_title>
    <acronym>MavaPET</acronym>
    <official_title>Coronary Flow Reserve in oHCM Patients Before and After 12 Months of Standard-of-care Mavacamten Treatment as Assessed by PET/CT</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Michael Ayers</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Bristol-Myers Squibb</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Virginia</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this observational study is to measure the effect of mavacamten treatment on&#xD;
        blood flow in the heart muscle (myocardium) in patients with obstructive hypertrophic&#xD;
        cardiomyopathy. The main question it aims to answer is:&#xD;
  &#xD;
        • Does mavacamten treatment improve blood flow in the heart muscle?&#xD;
  &#xD;
        Participants will take mavacamten at the direction of their treating physician. Participants&#xD;
        will complete 2 myocardial Positron Emission Tomography and Computed Tomography (PET-CT)&#xD;
        scans. The first scan will be completed before participants start taking mavacamten. The scan&#xD;
        will be repeated after 12 months of mavacamten treatment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a single-arm, before-and-after investigation of the effect of mavacamten therapy on&#xD;
        myocardial blood flows in adult human subjects prescribed mavacamten for clinical standard of&#xD;
        care for oHCM. We hypothesize that 12 months of mavacamten therapy will improve myocardial&#xD;
        blood flows as assessed by PET/CT. The investigation will take place at a single site.&#xD;
        Participants who consent will be prospectively enrolled once mavacamten therapy has been&#xD;
        approved by their health insurance/payer. Enrolled participants will undergo myocardial&#xD;
        PET/CT before starting mavacamten and after 12 months of therapy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2026</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Change in myocardial perfusion reserve after 12 months of mavacamten treatment.</measure>
      <time_frame>12 months</time_frame>
      <description>Myocardial perfusion reserve is the ratio of global myocardial blood flow at stress versus rest.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Obstructive Hypertrophic Cardiomyopathy</condition>
    <arm_group>
      <arm_group_label>Cohort 1</arm_group_label>
      <description>Clinically stable, adult patients with obstructive hypertrophic cardiomyopathy, who meet mavacamten prescribing guidelines will be prescribed mavacamten by their treating physician.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>mavacamten</intervention_name>
      <description>Study participants will receive mavacamten under the standard of care</description>
      <arm_group_label>Cohort 1</arm_group_label>
      <other_name>Camzyos</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Clinically stable adult obstructive hypertrophic cardiomyopathy patients on background&#xD;
          therapy who have been prescribed Camzyos (mavacamten) in accordance with the US Prescribing&#xD;
          Information, but who have not yet started this medication.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Willingness and ability to provide written informed consent&#xD;
  &#xD;
            2. Willingness and ability to comply with scheduled visits and study procedures&#xD;
  &#xD;
            3. Male or female, aged 18-85 years&#xD;
  &#xD;
            4. Diagnosed with obstructive hypertrophic cardiomyopathy according to presence of a left&#xD;
               ventricular wall thickness of ≥15 mm that is otherwise unexplained by abnormal loading&#xD;
               conditions (e.g., hypertension, valvular, congenital disease) or infiltrative&#xD;
               cardiomyopathies. Unexplained left ventricular wall thickness of ≥13 mm is sufficient&#xD;
               for diagnosis in relatives of individuals with hypertrophic cardiomyopathy or those&#xD;
               who are genotype positive.&#xD;
  &#xD;
            5. Has been prescribed mavacamten consistent with US Prescribing Information&#xD;
  &#xD;
            6. Ability and intention to adhere to oral mavacamten therapy as prescribed by treating&#xD;
               physician for the duration of study participation&#xD;
  &#xD;
            7. For females of reproductive potential: negative pregnancy test at screening/baseline&#xD;
               and 12 month visits.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Pregnancy or lactation&#xD;
  &#xD;
            2. Known hypersensitivity to components of mavacamten or regadenoson&#xD;
  &#xD;
            3. Prior treatment with mavacamten or aficamten&#xD;
  &#xD;
          11. Over weight limit for imaging gantry. 12. To minimize the risk of participants&#xD;
          undergoing PET/CT with inadequate image quality, participants with left ventricular&#xD;
          systolic dysfunction or lung disease will be excluded.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>University of Virginia</name>
        <address>
          <city>Charlottesville</city>
          <state>Virginia</state>
          <zip>22908</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>University of Virginia</investigator_affiliation>
      <investigator_full_name>Michael Ayers</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cardiomyopathies</mesh_term>
      <mesh_term>Cardiomyopathy, Hypertrophic</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>No data on individual participants will be shared outside the University of Virginia.</ipd_description>
    </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/NCT06023186
  org study id: HSR220293
  nct id: NCT06023186
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  The goal of this observational study is to measure the effect of mavacamten treatment on
        blood flow in the heart muscle (myocardium) in patients with obstructive hypertrophic
        cardiomyopathy. The main question it aims to answer is:
  
        • Does mavacamten treatment improve blood flow in the heart muscle?
  
        Participants will take mavacamten at the direction of their treating physician. Participants
        will complete 2 myocardial Positron Emission Tomography and Computed Tomography (PET-CT)
        scans. The first scan will be completed before participants start taking mavacamten. The scan
        will be repeated after 12 months of mavacamten treatment.
  This is a single-arm, before-and-after investigation of the effect of mavacamten therapy on
        myocardial blood flows in adult human subjects prescribed mavacamten for clinical standard of
        care for oHCM. We hypothesize that 12 months of mavacamten therapy will improve myocardial
        blood flows as assessed by PET/CT. The investigation will take place at a single site.
        Participants who consent will be prospectively enrolled once mavacamten therapy has been
        approved by their health insurance/payer. Enrolled participants will undergo myocardial
        PET/CT before starting mavacamten and after 12 months of therapy.
  observational model: Case-Only
  time perspective: Prospective
  measure: Change in myocardial perfusion reserve after 12 months of mavacamten treatment.
  time frame: 12 months
  description: Myocardial perfusion reserve is the ratio of global myocardial blood flow at stress versus rest.
  arm group label: Cohort 1
  description: Clinically stable, adult patients with obstructive hypertrophic cardiomyopathy, who meet mavacamten prescribing guidelines will be prescribed mavacamten by their treating physician.
  intervention type: Drug
  intervention name: mavacamten
  description: Study participants will receive mavacamten under the standard of care
  arm group label: Cohort 1
  other name: Camzyos
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: No
  facility: 
  country: United States
  responsible party type: Sponsor-Investigator
  investigator affiliation: University of Virginia
  investigator full name: Michael Ayers
  investigator title: Assistant Professor
  mesh term: Cardiomyopathies
  mesh term: Cardiomyopathy, Hypertrophic
  sharing ipd: No
  ipd description: No data on individual participants will be shared outside the University of Virginia.