<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/NCT03269630</url>
  </required_header>
  <id_info>
    <org_study_id>LSU</org_study_id>
    <nct_id>NCT03269630</nct_id>
  </id_info>
  <brief_title>New Orleans Pulmonary Hypertension Biobank</brief_title>
  <acronym>NO-PH Biobank</acronym>
  <official_title>New Orleans Pulmonary Hypertension Biobank</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Louisiana State University Health Sciences Center in New Orleans</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Louisiana State University Health Sciences Center in New Orleans</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>
      Pulmonary hypertension (PH) is a serious condition characterized by a mean pulmonary artery&#xD;
      pressure &gt;=25mmHg on right heart catheterization (RHC). Despite advances in PH care, outcomes&#xD;
      are still sub-optimal and further research is required into the pathobiology of the disease&#xD;
      and development of biomarkers that can guide clinical care. The investigators are&#xD;
      establishing a biobank to collect samples (blood, urine, stool) from patients with pulmonary&#xD;
      hypertension, patients at high risk for pulmonary hypertension, healthy controls, and&#xD;
      patients undergoing right heart catheterization. Specimens will be stored for future&#xD;
      investigations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 29, 2017</start_date>
  <completion_date type="Anticipated">October 2027</completion_date>
  <primary_completion_date type="Anticipated">October 2027</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Collection of biospecimens</measure>
    <time_frame>10 years</time_frame>
    <description>Biospecimen collection only</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">450</enrollment>
  <condition>Pulmonary Hypertension</condition>
  <condition>Systemic Sclerosis</condition>
  <condition>Mixed Connective Tissue Disease</condition>
  <condition>Heart Failure With Normal Ejection Fraction</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Clinic patients (Comprehensive Pulmonary Hypertension Center)</arm_group_label>
    <description>Pulmonary hypertension patients (WHO group 1-5)&#xD;
Systemic sclerosis patients without pulmonary hypertension&#xD;
Mixed connective tissue disease patients without pulmonary hypertension</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Outpatient right heart catheterization patients</arm_group_label>
    <description>-Outpatients undergoing right heart catheterization for any indication</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy controls</arm_group_label>
    <description>Age&gt;18&#xD;
Not actively smoking&#xD;
No chronic medical conditions</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention. Biospecimen collection only</intervention_name>
    <description>Biospecimen collection</description>
    <arm_group_label>Clinic patients (Comprehensive Pulmonary Hypertension Center)</arm_group_label>
    <arm_group_label>Healthy controls</arm_group_label>
    <arm_group_label>Outpatient right heart catheterization patients</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood (serum, plasma, buffy coat, PBMCs) Urine Stool&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects will be enrolled from 2 venues: 1) Comprehensive Pulmonary Hypertension Center&#xD;
        clinic (pulmonary hypertension, systemic sclerosis without PH, mixed connective tissue&#xD;
        disease without PH) and 2) Outpatient right heart catheterization lab. Healthy subjects&#xD;
        (age&gt;18, not currently smoking, no chronic medical conditions) will also be enrolled.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of pulmonary hypertension and followed at the Comprehensive Pulmonary&#xD;
             Hypertension Center OR&#xD;
&#xD;
          -  Diagnosis of systemic sclerosis and followed at the Comprehensive Pulmonary&#xD;
             Hypertension Center OR&#xD;
&#xD;
          -  Diagnosis of mixed connective tissue disease and followed at the Comprehensive&#xD;
             Pulmonary Hypertension Center OR&#xD;
&#xD;
          -  Undergoing outpatient right heart catheterization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age&lt;18&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Unable to understand English&#xD;
&#xD;
          -  Currently incarcerated&#xD;
&#xD;
          -  Unwilling or unable to sign informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Matthew R Lammi, MD, MSCR</last_name>
    <phone>5045684634</phone>
    <email>mlammi@lsuhsc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Medical Center-New Orleans</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matthew Lammi, MD, MSCR</last_name>
      <phone>504-568-4634</phone>
      <email>mlammi@lsuhsc.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>September 9, 2021</last_update_submitted>
  <last_update_submitted_qc>September 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Louisiana State University Health Sciences Center in New Orleans</investigator_affiliation>
    <investigator_full_name>Matthew Lammi</investigator_full_name>
    <investigator_title>Associate Professor of Medicine</investigator_title>
  </responsible_party>
  <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>Scleroderma, Systemic</mesh_term>
    <mesh_term>Scleroderma, Diffuse</mesh_term>
    <mesh_term>Connective Tissue Diseases</mesh_term>
    <mesh_term>Mixed Connective Tissue Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>A sharing plan will be developed to share biospecimens with interested researchers.</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/NCT03269630
org study id: LSU
nct id: NCT03269630
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pulmonary hypertension (PH) is a serious condition characterized by a mean pulmonary artery
      pressure >=25mmHg on right heart catheterization (RHC). Despite advances in PH care, outcomes
      are still sub-optimal and further research is required into the pathobiology of the disease
      and development of biomarkers that can guide clinical care. The investigators are
      establishing a biobank to collect samples (blood, urine, stool) from patients with pulmonary
      hypertension, patients at high risk for pulmonary hypertension, healthy controls, and
      patients undergoing right heart catheterization. Specimens will be stored for future
      investigations.
observational model: Other
time perspective: Prospective
measure: Collection of biospecimens
time frame: 10 years
description: Biospecimen collection only
arm group label: Clinic patients (Comprehensive Pulmonary Hypertension Center)
description: Pulmonary hypertension patients (WHO group 1-5)
Systemic sclerosis patients without pulmonary hypertension
Mixed connective tissue disease patients without pulmonary hypertension
arm group label: Outpatient right heart catheterization patients
description: -Outpatients undergoing right heart catheterization for any indication
arm group label: Healthy controls
description: Age>18
Not actively smoking
No chronic medical conditions
intervention type: Other
intervention name: No intervention. Biospecimen collection only
description: Biospecimen collection
arm group label: Clinic patients (Comprehensive Pulmonary Hypertension Center)
arm group label: Healthy controls
arm group label: Outpatient right heart catheterization patients
Blood (serum, plasma, buffy coat, PBMCs) Urine Stool
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Matthew R Lammi, MD, MSCR
phone: 5045684634
email: mlammi@lsuhsc.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Louisiana State University Health Sciences Center in New Orleans
investigator full name: Matthew Lammi
investigator title: Associate Professor of Medicine
mesh term: Hypertension, Pulmonary
mesh term: Hypertension
mesh term: Scleroderma, Systemic
mesh term: Scleroderma, Diffuse
mesh term: Connective Tissue Diseases
mesh term: Mixed Connective Tissue Disease
sharing ipd: Yes
ipd description: A sharing plan will be developed to share biospecimens with interested researchers.