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/NCT06025500</url>
    </required_header>
    <id_info>
      <org_study_id>ENDURANCE</org_study_id>
      <nct_id>NCT06025500</nct_id>
    </id_info>
    <brief_title>Analysing Peripheral Skeletal Muscle Function Before and After Endobronchial Valve Treatment</brief_title>
    <acronym>ENDURANCE</acronym>
    <official_title>Analysing cEllular Bioenergetics aNd Structural aDaptations in the qUadriceps Muscle befoRe and After endobroNChial Valve treatmEnt</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Medical Center Groningen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Medical Center Groningen</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>
        Rationale: Chronic obstructive pulmonary disease (COPD) is characterised by a high prevalence&#xD;
        of peripheral muscle dysfunction, which can have significant clinical consequences, including&#xD;
        decreased exercise capacity, reduced quality of life, and even a higher mortality rate.&#xD;
        Reduction of lung hyperinflation using bronchoscopic lung volume reduction treatment with&#xD;
        one-way endobronchial valves (EBV) is a minimally invasive intervention which improves&#xD;
        exercise capacity and physical activity in patients with severe emphysema. This positive&#xD;
        effect is also related to weight gain and alterations in body composition. The physiologic&#xD;
        and structural adaptations of skeletal muscle function after EBV treatment has never been&#xD;
        investigated before.&#xD;
  &#xD;
        Objective: To investigate the physiological and structural adaptations of peripheral muscle&#xD;
        function at a cellular level in response to EBV treatment.&#xD;
  &#xD;
        Study design: A single center, prospective clinical trial with a single-arm pretest-posttest&#xD;
        design. Patients with severe emphysema who will receive a bronchoscopic lung volume reduction&#xD;
        treatment are asked to undergo additional in-magnet exercise testing and muscle biopsies&#xD;
        before and after placement of EBVs.&#xD;
  &#xD;
        Study population: Patients with severe emphysema who are scheduled to undergo EBV treatment.&#xD;
  &#xD;
        Main study parameters/endpoints: The difference in quadriceps phosphocreatine concentration&#xD;
        (PCr), quadriceps inorganic phosphorus concentration (Pi), and quadriceps pH at rest, during&#xD;
        progressive exercise, and recovery rate will be measured by 31P-MRS to assess the&#xD;
        physiological effect of EBV treatment on skeletal muscle function and its bioenergetics.&#xD;
        Furthermore, we will perform a detailed histological and biochemical analysis of muscle fiber&#xD;
        type composition, mitochondrial density, master regulators of muscle oxidative programming,&#xD;
        and mitochondrial respiration before and after EBV treatment.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">March 1, 2024</start_date>
    <completion_date type="Anticipated">December 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2025</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Change in quadriceps phosphocreatine concentration measured by 31P-MRS.</measure>
      <time_frame>6 months</time_frame>
      <description>To assess the physiological adaptations, in terms of cellular bioenergetics, of the quadriceps muscle in patients with severe COPD in response to EBV treatment. This will be done by performing 31P-MRS during exercise testing in a MR-compatible ergometer at baseline and at 6 months follow-up, for which the quadriceps phosphocreatine concentration (PCr) at rest and during progressive exercise will be assessed.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in muscle fiber type composition measured in muscle biopsies.</measure>
      <time_frame>6 months</time_frame>
      <description>Change in muscle fiber type composition 6 months after EBV treatment measured in muscle biopsies.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">15</enrollment>
    <condition>Emphysema</condition>
    <arm_group>
      <arm_group_label>EBV-patients</arm_group_label>
      <description>Patients who are scheduled for a bronchoscopic lung volume reduction treatment using endobronchial valves.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>31P-Magnetic Resonance Spectroscopy (31P-MRS)</intervention_name>
      <description>31P-Magnetic Resonance Spectroscopy will be performed during exercise testing.</description>
      <arm_group_label>EBV-patients</arm_group_label>
      <other_name>Muscle biopsy</other_name>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Muscle biopsies and peripheral blood collection&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          The study population exists of patients with severe emphysema who undergo a bronchoscopic&#xD;
          lung volume reduction treatment with one-way endobronchial valves.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient is scheduled for a bronchoscopic lung volume treatment using one-way&#xD;
               endobronchial valves;&#xD;
  &#xD;
            -  Patient read, understood and signed the Informed Consent Form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Inability to perform a cycle ergometry test;&#xD;
  &#xD;
            -  Contraindications for undergoing a magnetic resonance imaging scan (e.g.&#xD;
               claustrophobia, implanted cardiac devices);&#xD;
  &#xD;
            -  Body length &gt;190cm;&#xD;
  &#xD;
            -  Any anticoagulant therapy;&#xD;
  &#xD;
            -  COPD exacerbation 4 weeks prior to testing.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Dirk-Jan Slebos, MD PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>UMC Groningen</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Else ter Haar, MD</last_name>
      <phone>+31503619194</phone>
      <email>e.a.m.d.ter.haar@umcg.nl</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jorine Hartman, PhD</last_name>
      <phone>+31503619194</phone>
      <email>j.hartman@umcg.nl</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University Medical Center Groningen</investigator_affiliation>
      <investigator_full_name>Dirk-Jan Slebos</investigator_full_name>
      <investigator_title>Head of the department of Pulmonary Diseases and Pulmonologist</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Emphysema</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>Data can be shared on reasonable request</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/NCT06025500
  org study id: ENDURANCE
  nct id: NCT06025500
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Rationale: Chronic obstructive pulmonary disease (COPD) is characterised by a high prevalence
        of peripheral muscle dysfunction, which can have significant clinical consequences, including
        decreased exercise capacity, reduced quality of life, and even a higher mortality rate.
        Reduction of lung hyperinflation using bronchoscopic lung volume reduction treatment with
        one-way endobronchial valves (EBV) is a minimally invasive intervention which improves
        exercise capacity and physical activity in patients with severe emphysema. This positive
        effect is also related to weight gain and alterations in body composition. The physiologic
        and structural adaptations of skeletal muscle function after EBV treatment has never been
        investigated before.
  
        Objective: To investigate the physiological and structural adaptations of peripheral muscle
        function at a cellular level in response to EBV treatment.
  
        Study design: A single center, prospective clinical trial with a single-arm pretest-posttest
        design. Patients with severe emphysema who will receive a bronchoscopic lung volume reduction
        treatment are asked to undergo additional in-magnet exercise testing and muscle biopsies
        before and after placement of EBVs.
  
        Study population: Patients with severe emphysema who are scheduled to undergo EBV treatment.
  
        Main study parameters/endpoints: The difference in quadriceps phosphocreatine concentration
        (PCr), quadriceps inorganic phosphorus concentration (Pi), and quadriceps pH at rest, during
        progressive exercise, and recovery rate will be measured by 31P-MRS to assess the
        physiological effect of EBV treatment on skeletal muscle function and its bioenergetics.
        Furthermore, we will perform a detailed histological and biochemical analysis of muscle fiber
        type composition, mitochondrial density, master regulators of muscle oxidative programming,
        and mitochondrial respiration before and after EBV treatment.
  observational model: Cohort
  time perspective: Prospective
  measure: Change in quadriceps phosphocreatine concentration measured by 31P-MRS.
  time frame: 6 months
  description: To assess the physiological adaptations, in terms of cellular bioenergetics, of the quadriceps muscle in patients with severe COPD in response to EBV treatment. This will be done by performing 31P-MRS during exercise testing in a MR-compatible ergometer at baseline and at 6 months follow-up, for which the quadriceps phosphocreatine concentration (PCr) at rest and during progressive exercise will be assessed.
  measure: Change in muscle fiber type composition measured in muscle biopsies.
  time frame: 6 months
  description: Change in muscle fiber type composition 6 months after EBV treatment measured in muscle biopsies.
  arm group label: EBV-patients
  description: Patients who are scheduled for a bronchoscopic lung volume reduction treatment using endobronchial valves.
  intervention type: Diagnostic Test
  intervention name: 31P-Magnetic Resonance Spectroscopy (31P-MRS)
  description: 31P-Magnetic Resonance Spectroscopy will be performed during exercise testing.
  arm group label: EBV-patients
  other name: Muscle biopsy
  Muscle biopsies and peripheral blood collection
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Dirk-Jan Slebos, MD PhD
  role: Principal Investigator
  affiliation: UMC Groningen
  last name: Else ter Haar, MD
  phone: +31503619194
  email: e.a.m.d.ter.haar@umcg.nl
  last name: Jorine Hartman, PhD
  phone: +31503619194
  email: j.hartman@umcg.nl
  responsible party type: Principal Investigator
  investigator affiliation: University Medical Center Groningen
  investigator full name: Dirk-Jan Slebos
  investigator title: Head of the department of Pulmonary Diseases and Pulmonologist
  mesh term: Emphysema
  sharing ipd: Undecided
  ipd description: Data can be shared on reasonable request