<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/NCT02237378</url>
  </required_header>
  <id_info>
    <org_study_id>20140602</org_study_id>
    <nct_id>NCT02237378</nct_id>
  </id_info>
  <brief_title>A Pilot Study Evaluating Heart and Lung Metabolism in Pulmonary Hypertension Associated With Left Heart Disease</brief_title>
  <official_title>Evaluation of Cardiopulmonary Metabolism and Pulmonary Vascular Remodeling in Pulmonary Hypertension Associated With Left Heart Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Heart Institute Research Corporation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ottawa Heart Institute Research Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Right ventricular (RV) failure is the leading cause of death in pulmonary arterial&#xD;
      hypertension. (PAH) Right ventricular ejection fraction is one of the most important&#xD;
      predictors of prognosis in heart failure patients regardless of cause. It is estimated that&#xD;
      30-50% of patients with heart failure and preserved ejection fraction (HFpEF) have right&#xD;
      ventricular dysfunction and up to 70% of these patients will have significant pulmonary&#xD;
      hypertension (PH), both of which are related to much worse prognosis. Right ventricular&#xD;
      failure is becoming an increasingly prevalent and significant cause of morbidity in patients&#xD;
      with left heart disease. Despite the significance of RV function to survival, there are no&#xD;
      therapies available that directly or selectively improve RV function.&#xD;
&#xD;
      The overall theme of this research project is to evaluate the mechanisms that contribute to&#xD;
      the cause of right heart failure. This small study is designed to look at the role of heart&#xD;
      and lung metabolism and pulmonary hypertension as they relate to the development of right&#xD;
      heart failure in cardiovascular disease.(PH-LHD)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The hemodynamic definition of PH-LHD involves a mean pulmonary artery pressure (mPAP) &gt;25mm&#xD;
      Hg at rest and pulmonary capillary wedge pressure (PCWP) of ≥15.The coexistence of mitral&#xD;
      insufficiency is also a characteristic of PH-LHD. HFpEF is a condition caused by impaired&#xD;
      relaxation of a stiffened myocardium as a consequence of an increased load to the left&#xD;
      ventricle due to elevated systemic pressures.&#xD;
&#xD;
      Pulmonary hemodynamics can be used to classify PH LHD as either passive or reactive,&#xD;
      irrespective of LV function. It has been suggested that diastolic pressure gradient (DPG) may&#xD;
      offer added prognostic value as a more accurate indicator of pulmonary vascular remodeling.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Poor enrolment&#xD;
  </why_stopped>
  <start_date type="Actual">December 2014</start_date>
  <completion_date type="Actual">August 2018</completion_date>
  <primary_completion_date type="Actual">August 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiac and pulmonary metabolism role in development of right heart failure in pulmonary hypertension in left heart disease.</measure>
    <time_frame>Baseline</time_frame>
    <description>Relationship between lung fludeoxyglucose (FDG)uptake and hemodynamic type pulmonary hypertension using PET scanning</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Pulmonary Hypertension</condition>
  <arm_group>
    <arm_group_label>FDG PET scan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A PET scan using F-18 FDG, N-13 Ammonia will be performed</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>FDG PET scan</intervention_name>
    <description>Following an overnight fast, subjects will be positioned in the Discovery 660 PET/VCT scanner. Following a scout scan to confirm patient positioning, low dose xray CT scan is performed for photon attenuation. A 20 minute dynamic PET scan is started simultaneously with 3 MBq/kg of N-13 ammonia to measure myocardial perfusion. Following N-13 decay,a 60 minute dynamic PET scan with 3 MBq/kg F-18- FDG to measure myocardial glucose uptake. Blood sampling for glucose and insulin will occur at pre specified time points throughout the scan.</description>
    <arm_group_label>FDG PET scan</arm_group_label>
    <other_name>F-18-FDG</other_name>
    <other_name>N-13 ammonia</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must be able to provide their written informed consent to participate in the&#xD;
             study after having received adequate previous information and prior to any study&#xD;
             specific procedures.&#xD;
&#xD;
          -  At least 18 years of age at the time of screening.&#xD;
&#xD;
          -  Patients with PH secondary to left heart disease (known as group II PH) defined as a&#xD;
             mean PAP&gt;25 mmHg and a PCWP of ≥15 mmHg.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All other types of pulmonary hypertension including Dana Point Classification Group 1,&#xD;
             3, 5.&#xD;
&#xD;
          -  Type II Diabetes mellitus requiring medical therapy&#xD;
&#xD;
          -  Previous myocardial infarction within the 3 months prior to screening.&#xD;
&#xD;
          -  Renal insufficiency (glomerular filtration rate &lt; 30 ml/min.&#xD;
&#xD;
          -  ALT or AST &gt; 3times ULN and/or severe hepatic insufficiency.&#xD;
&#xD;
          -  Contraindication to MRI imaging.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lisa M Mielniczuk, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Ottawa Heart Institiute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of OttawaHeart Institute</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y4W7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>August 28, 2018</last_update_submitted>
  <last_update_submitted_qc>August 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>FDG lung and RV uptake</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension, Pulmonary</mesh_term>
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Only 2 participants were enrolled in this study. One of the main reasons was no clinical indication to repeat a right heart catherization in this population.</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/NCT02237378
org study id: 20140602
nct id: NCT02237378
lead sponsor: 
has dmc: No
Right ventricular (RV) failure is the leading cause of death in pulmonary arterial
      hypertension. (PAH) Right ventricular ejection fraction is one of the most important
      predictors of prognosis in heart failure patients regardless of cause. It is estimated that
      30-50% of patients with heart failure and preserved ejection fraction (HFpEF) have right
      ventricular dysfunction and up to 70% of these patients will have significant pulmonary
      hypertension (PH), both of which are related to much worse prognosis. Right ventricular
      failure is becoming an increasingly prevalent and significant cause of morbidity in patients
      with left heart disease. Despite the significance of RV function to survival, there are no
      therapies available that directly or selectively improve RV function.

      The overall theme of this research project is to evaluate the mechanisms that contribute to
      the cause of right heart failure. This small study is designed to look at the role of heart
      and lung metabolism and pulmonary hypertension as they relate to the development of right
      heart failure in cardiovascular disease.(PH-LHD)
The hemodynamic definition of PH-LHD involves a mean pulmonary artery pressure (mPAP) >25mm
      Hg at rest and pulmonary capillary wedge pressure (PCWP) of ≥15.The coexistence of mitral
      insufficiency is also a characteristic of PH-LHD. HFpEF is a condition caused by impaired
      relaxation of a stiffened myocardium as a consequence of an increased load to the left
      ventricle due to elevated systemic pressures.

      Pulmonary hemodynamics can be used to classify PH LHD as either passive or reactive,
      irrespective of LV function. It has been suggested that diastolic pressure gradient (DPG) may
      offer added prognostic value as a more accurate indicator of pulmonary vascular remodeling.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Cardiac and pulmonary metabolism role in development of right heart failure in pulmonary hypertension in left heart disease.
time frame: Baseline
description: Relationship between lung fludeoxyglucose (FDG)uptake and hemodynamic type pulmonary hypertension using PET scanning
arm group label: FDG PET scan
arm group type: Experimental
description: A PET scan using F-18 FDG, N-13 Ammonia will be performed
intervention type: Radiation
intervention name: FDG PET scan
description: Following an overnight fast, subjects will be positioned in the Discovery 660 PET/VCT scanner. Following a scout scan to confirm patient positioning, low dose xray CT scan is performed for photon attenuation. A 20 minute dynamic PET scan is started simultaneously with 3 MBq/kg of N-13 ammonia to measure myocardial perfusion. Following N-13 decay,a 60 minute dynamic PET scan with 3 MBq/kg F-18- FDG to measure myocardial glucose uptake. Blood sampling for glucose and insulin will occur at pre specified time points throughout the scan.
arm group label: FDG PET scan
other name: F-18-FDG
other name: N-13 ammonia
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lisa M Mielniczuk, MD
role: Principal Investigator
affiliation: University of Ottawa Heart Institiute
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Hypertension, Pulmonary
mesh term: Hypertension
mesh term: Heart Diseases
sharing ipd: No
ipd description: Only 2 participants were enrolled in this study. One of the main reasons was no clinical indication to repeat a right heart catherization in this population.