<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/NCT01730092</url>
  </required_header>
  <id_info>
    <org_study_id>130012</org_study_id>
    <secondary_id>13-CC-0012</secondary_id>
    <nct_id>NCT01730092</nct_id>
  </id_info>
  <brief_title>Natural History Study of Biomarkers in Pulmonary Arterial Hypertension</brief_title>
  <official_title>A Natural History Study of Novel Biomarkers in Pulmonary Arterial Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institutes of Health Clinical Center (CC)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      - High blood pressure in the lungs, known as pulmonary arterial hypertension (PAH), is a rare&#xD;
      disorder. Some people have disease-associated PAH and some have PAH from an unknown cause.&#xD;
      Researchers want to follow the natural history of all PAH patients to understand how PAH&#xD;
      progresses in order to discover targets for future research into new treatments. To further&#xD;
      identify treatment targets, they will compare healthy volunteers to patients with PAH.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      - To study the natural history of PAH.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
        -  Individuals at least 18 years of age who have PAH.&#xD;
&#xD;
        -  Healthy volunteers at least 18 years of age.&#xD;
&#xD;
      Design:&#xD;
&#xD;
        -  Participants with PAH will have periodic visits to the National Institutes of Health&#xD;
           Clinical Center. After the first visit, they will return in 6 months and then yearly or&#xD;
           every other year for as long as the study continues.&#xD;
&#xD;
        -  The first visit will take up to 3 days. It will involve the following tests:&#xD;
&#xD;
        -  Physical exam and medical history&#xD;
&#xD;
        -  Blood and urine samples&#xD;
&#xD;
        -  Heart and lung function tests and imaging studies&#xD;
&#xD;
        -  Six-minute walk test&#xD;
&#xD;
        -  Questions about exercise and physical activity&#xD;
&#xD;
        -  Healthy volunteers will have only one visit to the Clinical Center, during which they&#xD;
           will undergo screening tests, and complete many of the same tests as patients with PAH&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction:&#xD;
&#xD;
      Pulmonary arterial hypertension (PAH) is a rare disorder associated with poor survival.&#xD;
      Endothelial dysfunction resulting from 1) genetic susceptibility, and 2) a triggering&#xD;
      stimulus that initiates pulmonary vascular injury, the two-hit hypothesis, appears to play a&#xD;
      central role both in the pathogenesis and progression of PAH. Inflammation appears to drive&#xD;
      this dysfunctional endothelial phenotype, propagating cycles of injury and repair in&#xD;
      genetically susceptible patients with idiopathic PAH (IPAH) and patients with&#xD;
      disease-associated PAH. However, despite mounting evidence of vascular inflammation in&#xD;
      patients with PAH, detailed phenotypic studies are lacking on the temporal evolution of this&#xD;
      process and its contribution to right ventricular (RV) and pulmonary vascular remodeling. We&#xD;
      hypothesize that a detailed characterization of the temporal evolution of vascular&#xD;
      inflammation in PAH and its impact on RV and pulmonary vascular function will add prognostic&#xD;
      value to traditional measures of disease severity and suggest novel therapeutic targets for&#xD;
      future research.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      Patients with IPAH and disease-associated PAH will be recruited to the NIH and enrolled in&#xD;
      this natural history study investigating the ability of circulating markers of vascular&#xD;
      inflammation as well as high-resolution cardiac magnetic resonance imaging (MRI) to&#xD;
      accurately stage severity of disease and/or predict clinically relevant outcomes.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      The total population for the study will be 150 PAH subjects and approximately 55 age and&#xD;
      gender matched controls (i.e. each healthy volunteer is matched to less than or equal to 3&#xD;
      PAH subjects).&#xD;
&#xD;
      PAH subjects will undergo 1) standard clinical examinations including 6-minute walk distance&#xD;
      and echocardiography; 2) cardiopulmonary exercise testing; 3) markers of coagulation and&#xD;
      fibrotic disease; 4) plasma profiling of inflammatory&#xD;
&#xD;
      markers; 5) gene expression profiling of peripheral blood mononuclear cells PBMCs); 6)&#xD;
      high-resolution MRI-based determination of pulmonary vascularand RV structure and function&#xD;
      and 7) Cardiac CT scan.&#xD;
&#xD;
      Plasma markers of endothelial inflammation, PBMC expression profiles, and high-resolution&#xD;
      cardiac MRI will also be studied in age and gender matched controls to define normal ranges&#xD;
      and variability for each of these novel assessments. Comparison of these results to PAH&#xD;
      subjects at baseline will be used to determine the degree to which these investigative tests&#xD;
      distinguish PAH patients from healthy subjects. Likewise, baseline clinical evaluations of&#xD;
      PAH subjects will be used to examine whether any novel test (inflammatory markers, or cardiac&#xD;
      MRI), accurately classifies patients according to their disease severity. In addition, these&#xD;
      tests will be investigated prospectively for their ability to predict PAH disease&#xD;
      progression. Disease progression will be defined prospectively as a decrease in the 6-minute&#xD;
      walk distance of greater than or equal to10% from baseline or clinical worsening requiring an&#xD;
      escalation in therapy, hospitalization due to right heart failure, transplantation or death.&#xD;
&#xD;
      Additional plasma will be collected from PAH subjects and age/gender matched control&#xD;
      subjects. This material will be used to probe for new biomarkers and inflammatory factors&#xD;
      using discovery based approaches (i.e. Proteomics and pulmonary artery endothelial cell&#xD;
      bioassay).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 15, 2013</start_date>
  <primary_completion_date type="Anticipated">December 31, 2030</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>Examine whether any novel test (inflammatory markers or high resolution cardiac MRI), accurately classifies PAH subjects according to disease severity as assessed by their baseline 6-minute walk distance.</measure>
    <time_frame>10 years</time_frame>
    <description>Compare outcomes in PAH subjects with controls</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">270</enrollment>
  <condition>Pulmonary Disease</condition>
  <condition>Pulmonary Hypertension</condition>
  <arm_group>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <description>Enroll up to 120 healthy volunteers, in order to obtain approximately 55 evaluable healthy volunteers matched to pulmonary arterial hypertension subjects for age and gender</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pulmonary Arterial Hypertension Subjects</arm_group_label>
    <description>150 subjects with pulmonary arterial hypertension; male or female, age grater than or equal to 18 99 years</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        primary clinical for PAH and community sample for controls&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  INCLUSION AND EXCLUSION CRITERIA FOR PAH SUBJECTS&#xD;
&#xD;
        Inclusion Criteria for PAH Subjects:&#xD;
&#xD;
        The following parameters on RHC are required to meet the hemodynamic definition of PAH&#xD;
        (NYHA/WHO Group I PH):&#xD;
&#xD;
          -  mean pulmonary artery pressure of greater than 25 mmHg at rest,&#xD;
&#xD;
          -  pulmonary capillary wedge pressure of less than or equal to 15 mmHg (or a left&#xD;
             ventricular end-diastolic pressure of less than or equal to 12mmHg) and&#xD;
&#xD;
          -  pulmonary vascular resistance of greater than 3 Wood units (240 dyn s cm(5)).&#xD;
&#xD;
        For patients with suspected PAH (Group I PH) who have not undergone a RHC and/or additional&#xD;
        testing to confirm the diagnosis, this testing will be completed as clinically indicated&#xD;
        under a procedural consent. If clinically indicated (diagnostic) testing indicates that the&#xD;
        subject with suspected PAH does not in fact meet standard criteria for PAH (Group I PH),&#xD;
        then the subject will be removed from the study.&#xD;
&#xD;
        Exclusion Criteria for PAH Subjects:&#xD;
&#xD;
          -  Pregnant or breastfeeding women (all women of childbearing potential will be required&#xD;
             to have a screening urine or blood pregnancy test)&#xD;
&#xD;
          -  Age less than 18 years&#xD;
&#xD;
          -  Inability to provide informed written consent for participation in the study&#xD;
&#xD;
        INCLUSION AND EXCLUSION CRITERIA FOR HEALTHY CONTROL SUBJECTS&#xD;
&#xD;
        Inclusion Criteria for Control Subjects&#xD;
&#xD;
        Any healthy man or woman who is the appropriate age and gender for matching to a PAH&#xD;
        patient&#xD;
&#xD;
          -  Must be eligible for MRI and Gadolinium Based MRI studies&#xD;
&#xD;
          -  Must be eligible for CT and Iodine Based Contrast CT studies&#xD;
&#xD;
        Exclusion Criteria for Healthy Control Subjects&#xD;
&#xD;
          -  Current pregnancy or breastfeeding (All women of childbearing potential will be&#xD;
             required to have a screening urine or blood pregnancy test)&#xD;
&#xD;
          -  Electrocardiographic evidence of clinically relevant heart disease&#xD;
&#xD;
          -  Symptoms of coronary or cardiac insufficiency&#xD;
&#xD;
          -  More than one major risk factor for coronary artery disease (excluding age and gender)&#xD;
&#xD;
          -  Obesity (defined as a body mass index &gt; 30 kg/m(2))&#xD;
&#xD;
          -  History of underlying conditions/risk factors associated with pulmonary hypertension&#xD;
             such as collagen vascular disease, HIV infection, use of appetite suppressants,&#xD;
             chronic liver disease or cirrhosis of the liver, chronic thromboembolic disease,&#xD;
             congenital heart defects, hypoxemia and/or significant pulmonary parenchymal disease&#xD;
&#xD;
          -  Systemic hypertension that is not well controlled (i.e. blood pressure at the time of&#xD;
             screening greater than or equal to140/90 mmHg) in adults &lt; 60 years old or greater&#xD;
             than or equal to 150/90 mmHg in adults 60 years or older) on medications. Subjects&#xD;
             taking &gt; 2 anti-hypertensive medications will be excluded irrespective of their&#xD;
             current blood pressure at time of screening&#xD;
&#xD;
          -  Anemia, thrombocytopenia or coagulopathy&#xD;
&#xD;
          -  Renal insufficiency (defined as an estimated glomerular filtration rate of &lt; 60&#xD;
             mL/min/1.73m(2) of body surface area)&#xD;
&#xD;
          -  Active tobacco use (&gt; 6 months) in the past ten years, any tobacco use within 3 months&#xD;
             prior to the screening evaluation or any tobacco use prior to completion of the study&#xD;
&#xD;
          -  Inability to provide informed written consent for participation in the study&#xD;
&#xD;
          -  History of recreational drug use with the exception of marijuana (as long as marijuana&#xD;
             use was &gt; 3 months from the time of study screening).&#xD;
&#xD;
        Exclusion Criteria for MRI in Healthy Control Subjects and Subjects with PAH&#xD;
&#xD;
        These contraindications include but are not limited to the following devices or conditions:&#xD;
&#xD;
          1. Implanted cardiac pacemaker or defibrillator&#xD;
&#xD;
          2. Cochlear Implants&#xD;
&#xD;
          3. Ocular foreign body (e.g. metal shavings)&#xD;
&#xD;
          4. Embedded shrapnel fragments&#xD;
&#xD;
          5. Central nervous system aneurysm clips&#xD;
&#xD;
          6. Implanted neural stimulator&#xD;
&#xD;
          7. Any implanted device that is incompatible with MRI&#xD;
&#xD;
          8. Unsatisfactory performance status as judged by the referring physician such that the&#xD;
             subject could not tolerate an MRI scan. Examples of medical conditions that would not&#xD;
             be accepted would include unstable angina and severe dyspnea at rest&#xD;
&#xD;
          9. Subjects requiring monitored sedation for MRI studies&#xD;
&#xD;
         10. Subjects with a condition precluding entry into the scanner (e.g. morbid obesity,&#xD;
             claustrophobia, etc.)&#xD;
&#xD;
         11. Subjects with severe back-pain or motion disorders who will be unable to tolerate&#xD;
             supine positioning within the MRI scanner and hold still for the duration of the&#xD;
             examination.&#xD;
&#xD;
        Exclusion Criteria for Gadolinium Based MRI Studies Only:&#xD;
&#xD;
          1. History of severe allergic reaction to gadolinium contrast agents despite pre-&#xD;
             medication with diphenhydramine and prednisone&#xD;
&#xD;
          2. Chronic kidney disease (an estimated glomerular filtration rate of &lt; 60&#xD;
             mL/min/1.73m(2) of body surface area)&#xD;
&#xD;
        Exclusion Criteria for Cardiac Computed Tomography in Healthy Control Subjects and Subjects&#xD;
        with PAH:&#xD;
&#xD;
        1) Subjects with a condition precluding entry into the scanner (e.g. morbid&#xD;
&#xD;
        obesity, claustrophobia, etc.)&#xD;
&#xD;
        Exclusion Criteria for Iodine Based Contrast CTA Studies Only:&#xD;
&#xD;
          1. Serum creatinine &gt; 1.4 mg/dL&#xD;
&#xD;
          2. History of multiple myeloma&#xD;
&#xD;
          3. Use of metformin-containing products less than 24 hours prior to contrast&#xD;
             administration&#xD;
&#xD;
          4. History of significant allergic reaction to CTA contrast agents despite premedication&#xD;
             with diphenhydramine and prednisone&#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_official>
    <last_name>Michael A Solomon, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institutes of Health Clinical Center (CC)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Grace M Graninger, R.N.</last_name>
    <phone>(301) 496-9320</phone>
    <email>ggraninger@cc.nih.gov</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Michael A Solomon, M.D.</last_name>
    <phone>(301) 496-9320</phone>
    <email>msolomon@cc.nih.gov</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)</last_name>
      <phone>800-411-1222</phone>
      <phone_ext>TTY dial 711</phone_ext>
      <email>ccopr@nih.gov</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2013-CC-0012.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <reference>
    <citation>Badesch DB, Raskob GE, Elliott CG, Krichman AM, Farber HW, Frost AE, Barst RJ, Benza RL, Liou TG, Turner M, Giles S, Feldkircher K, Miller DP, McGoon MD. Pulmonary arterial hypertension: baseline characteristics from the REVEAL Registry. Chest. 2010 Feb;137(2):376-87. doi: 10.1378/chest.09-1140. Epub 2009 Oct 16.</citation>
    <PMID>19837821</PMID>
  </reference>
  <reference>
    <citation>Rubin LJ. Primary pulmonary hypertension. Chest. 1993 Jul;104(1):236-50. doi: 10.1378/chest.104.1.236. No abstract available.</citation>
    <PMID>8325077</PMID>
  </reference>
  <reference>
    <citation>D'Alonzo GE, Barst RJ, Ayres SM, Bergofsky EH, Brundage BH, Detre KM, Fishman AP, Goldring RM, Groves BM, Kernis JT, et al. Survival in patients with primary pulmonary hypertension. Results from a national prospective registry. Ann Intern Med. 1991 Sep 1;115(5):343-9. doi: 10.7326/0003-4819-115-5-343.</citation>
    <PMID>1863023</PMID>
  </reference>
  <verification_date>July 19, 2023</verification_date>
  <study_first_submitted>November 17, 2012</study_first_submitted>
  <study_first_submitted_qc>November 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>September 8, 2023</last_update_submitted>
  <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vascular Inflammation</keyword>
  <keyword>Microarray</keyword>
  <keyword>Right Ventricular Function</keyword>
  <keyword>Endothelial Dysfunction</keyword>
  <keyword>Magnetic Resonance Imaging</keyword>
  <keyword>Natural History</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension, Pulmonary</mesh_term>
    <mesh_term>Pulmonary Arterial Hypertension</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <!-- 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/NCT01730092
org study id: 130012
secondary id: 13-CC-0012
nct id: NCT01730092
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background:

      - High blood pressure in the lungs, known as pulmonary arterial hypertension (PAH), is a rare
      disorder. Some people have disease-associated PAH and some have PAH from an unknown cause.
      Researchers want to follow the natural history of all PAH patients to understand how PAH
      progresses in order to discover targets for future research into new treatments. To further
      identify treatment targets, they will compare healthy volunteers to patients with PAH.

      Objectives:

      - To study the natural history of PAH.

      Eligibility:

        -  Individuals at least 18 years of age who have PAH.

        -  Healthy volunteers at least 18 years of age.

      Design:

        -  Participants with PAH will have periodic visits to the National Institutes of Health
           Clinical Center. After the first visit, they will return in 6 months and then yearly or
           every other year for as long as the study continues.

        -  The first visit will take up to 3 days. It will involve the following tests:

        -  Physical exam and medical history

        -  Blood and urine samples

        -  Heart and lung function tests and imaging studies

        -  Six-minute walk test

        -  Questions about exercise and physical activity

        -  Healthy volunteers will have only one visit to the Clinical Center, during which they
           will undergo screening tests, and complete many of the same tests as patients with PAH
Introduction:

      Pulmonary arterial hypertension (PAH) is a rare disorder associated with poor survival.
      Endothelial dysfunction resulting from 1) genetic susceptibility, and 2) a triggering
      stimulus that initiates pulmonary vascular injury, the two-hit hypothesis, appears to play a
      central role both in the pathogenesis and progression of PAH. Inflammation appears to drive
      this dysfunctional endothelial phenotype, propagating cycles of injury and repair in
      genetically susceptible patients with idiopathic PAH (IPAH) and patients with
      disease-associated PAH. However, despite mounting evidence of vascular inflammation in
      patients with PAH, detailed phenotypic studies are lacking on the temporal evolution of this
      process and its contribution to right ventricular (RV) and pulmonary vascular remodeling. We
      hypothesize that a detailed characterization of the temporal evolution of vascular
      inflammation in PAH and its impact on RV and pulmonary vascular function will add prognostic
      value to traditional measures of disease severity and suggest novel therapeutic targets for
      future research.

      Objectives:

      Patients with IPAH and disease-associated PAH will be recruited to the NIH and enrolled in
      this natural history study investigating the ability of circulating markers of vascular
      inflammation as well as high-resolution cardiac magnetic resonance imaging (MRI) to
      accurately stage severity of disease and/or predict clinically relevant outcomes.

      Methods:

      The total population for the study will be 150 PAH subjects and approximately 55 age and
      gender matched controls (i.e. each healthy volunteer is matched to less than or equal to 3
      PAH subjects).

      PAH subjects will undergo 1) standard clinical examinations including 6-minute walk distance
      and echocardiography; 2) cardiopulmonary exercise testing; 3) markers of coagulation and
      fibrotic disease; 4) plasma profiling of inflammatory

      markers; 5) gene expression profiling of peripheral blood mononuclear cells PBMCs); 6)
      high-resolution MRI-based determination of pulmonary vascularand RV structure and function
      and 7) Cardiac CT scan.

      Plasma markers of endothelial inflammation, PBMC expression profiles, and high-resolution
      cardiac MRI will also be studied in age and gender matched controls to define normal ranges
      and variability for each of these novel assessments. Comparison of these results to PAH
      subjects at baseline will be used to determine the degree to which these investigative tests
      distinguish PAH patients from healthy subjects. Likewise, baseline clinical evaluations of
      PAH subjects will be used to examine whether any novel test (inflammatory markers, or cardiac
      MRI), accurately classifies patients according to their disease severity. In addition, these
      tests will be investigated prospectively for their ability to predict PAH disease
      progression. Disease progression will be defined prospectively as a decrease in the 6-minute
      walk distance of greater than or equal to10% from baseline or clinical worsening requiring an
      escalation in therapy, hospitalization due to right heart failure, transplantation or death.

      Additional plasma will be collected from PAH subjects and age/gender matched control
      subjects. This material will be used to probe for new biomarkers and inflammatory factors
      using discovery based approaches (i.e. Proteomics and pulmonary artery endothelial cell
      bioassay).
observational model: Case-Control
time perspective: Prospective
measure: Examine whether any novel test (inflammatory markers or high resolution cardiac MRI), accurately classifies PAH subjects according to disease severity as assessed by their baseline 6-minute walk distance.
time frame: 10 years
description: Compare outcomes in PAH subjects with controls
arm group label: Healthy Volunteers
description: Enroll up to 120 healthy volunteers, in order to obtain approximately 55 evaluable healthy volunteers matched to pulmonary arterial hypertension subjects for age and gender
arm group label: Pulmonary Arterial Hypertension Subjects
description: 150 subjects with pulmonary arterial hypertension; male or female, age grater than or equal to 18 99 years
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Michael A Solomon, M.D.
role: Principal Investigator
affiliation: National Institutes of Health Clinical Center (CC)
last name: Grace M Graninger, R.N.
phone: (301) 496-9320
email: ggraninger@cc.nih.gov
last name: Michael A Solomon, M.D.
phone: (301) 496-9320
email: msolomon@cc.nih.gov
facility: 
status: Recruiting
contact: 
country: United States
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2013-CC-0012.html
description: NIH Clinical Center Detailed Web Page
citation: Badesch DB, Raskob GE, Elliott CG, Krichman AM, Farber HW, Frost AE, Barst RJ, Benza RL, Liou TG, Turner M, Giles S, Feldkircher K, Miller DP, McGoon MD. Pulmonary arterial hypertension: baseline characteristics from the REVEAL Registry. Chest. 2010 Feb;137(2):376-87. doi: 10.1378/chest.09-1140. Epub 2009 Oct 16.
PMID: 19837821
citation: Rubin LJ. Primary pulmonary hypertension. Chest. 1993 Jul;104(1):236-50. doi: 10.1378/chest.104.1.236. No abstract available.
PMID: 8325077
citation: D'Alonzo GE, Barst RJ, Ayres SM, Bergofsky EH, Brundage BH, Detre KM, Fishman AP, Goldring RM, Groves BM, Kernis JT, et al. Survival in patients with primary pulmonary hypertension. Results from a national prospective registry. Ann Intern Med. 1991 Sep 1;115(5):343-9. doi: 10.7326/0003-4819-115-5-343.
PMID: 1863023
responsible party type: Sponsor
mesh term: Hypertension, Pulmonary
mesh term: Pulmonary Arterial Hypertension
mesh term: Hypertension