<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/NCT03039972</url>
  </required_header>
  <id_info>
    <org_study_id>AZ 239/16</org_study_id>
    <nct_id>NCT03039972</nct_id>
  </id_info>
  <brief_title>Changes in Renal Function and Body Composition in Pulmonary Hypertension</brief_title>
  <official_title>Prospective Evaluation of Changes in Renal Function and Body Composition in Patients With Pulmonary Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Giessen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Giessen</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>
      Changes in renal function and body composition in patients with pulmonary hypertension&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective single-center study is designed to analyze changes in renal function and&#xD;
      body composition in patients with suspected or pre-diagnosed pulmonary hypertension at&#xD;
      pulmonary hypertension outpatient clinic, University Hospital Giessen and Marburg, Campus&#xD;
      Giessen.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 25, 2017</start_date>
  <completion_date type="Actual">July 9, 2020</completion_date>
  <primary_completion_date type="Actual">October 7, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Changes in renal function in patients with pulmonary hypertension</measure>
    <time_frame>1 year</time_frame>
    <description>Estimated GFR based on Chronic Kidney Disease Epidemiology Collaboration-creatinine-cystatin C will be used to determine renal function at baseline and at 1 year follow-up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in hydration status in patients with pulmonary hypertension</measure>
    <time_frame>1 year</time_frame>
    <description>Bioimpedance analysis will be used to determine hydration status at baseline and at 1 year follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in nutritional status in patients with pulmonary hypertension</measure>
    <time_frame>1 year</time_frame>
    <description>Bioimpedance analysis will be used to determine lean tissue and fat mass at baseline and at 1 year follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prognostic value of baseline renal function, hydration and nutritional status on pulmonary hypertension-associated morbidity and mortality</measure>
    <time_frame>1 year</time_frame>
    <description>pulmonary hypertension-associated morbidity and mortality (defined as escalation of pulmonary hypertension-specific therapy, unscheduled hospitalization and all-cause mortality) will be prospectively assessed during follow-up period</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">500</enrollment>
  <condition>Pulmonary Hypertension</condition>
  <condition>Renal Function Abnormal</condition>
  <arm_group>
    <arm_group_label>Pulmonary Hypertension</arm_group_label>
    <description>Adult outpatients with suspected or prediagnosed pulmonary hypertension irrespective of subclass and all chronic kidney disease stages</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>No intervention</description>
    <arm_group_label>Pulmonary Hypertension</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Collection of only residual material (blood, urine) for Deutsche Zentrum für Lungenforschung&#xD;
      Biobank.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with suspected or pre-diagnosed pulmonary hypertension at pulmonary&#xD;
        hypertension outpatient clinic, University Hospital Giessen and Marburg, Campus Giessen&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects older than 18 years at pulmonary hypertension outpatient clinic&#xD;
&#xD;
          -  Subjects who signed informed consent forms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients refusing to participate or withdraw consent during follow-up&#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>Werner Seeger, MD</last_name>
    <role>Study Director</role>
    <affiliation>Department of Internal Medicine II, Division of Pulmonology, Nephrology and Critical Care Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Clinic Giessen and Marburg - Campus Giessen</name>
      <address>
        <city>Giessen</city>
        <state>Hessen</state>
        <zip>35392</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Bellomo R, Prowle JR, Echeverri JE. Diuretic therapy in fluid-overloaded and heart failure patients. Contrib Nephrol. 2010;164:153-163. doi: 10.1159/000313728. Epub 2010 Apr 20.</citation>
    <PMID>20428001</PMID>
  </reference>
  <reference>
    <citation>Ronco C, Verger C, Crepaldi C, Pham J, De Los Rios T, Gauly A, Wabel P, Van Biesen W; IPOD-PD Study Group. Baseline hydration status in incident peritoneal dialysis patients: the initiative of patient outcomes in dialysis (IPOD-PD study)dagger. Nephrol Dial Transplant. 2015 May;30(5):849-58. doi: 10.1093/ndt/gfv013. Epub 2015 Mar 11.</citation>
    <PMID>25762355</PMID>
  </reference>
  <results_reference>
    <citation>Navaneethan SD, Wehbe E, Heresi GA, Gaur V, Minai OA, Arrigain S, Nally JV Jr, Schold JD, Rahman M, Dweik RA. Presence and outcomes of kidney disease in patients with pulmonary hypertension. Clin J Am Soc Nephrol. 2014 May;9(5):855-63. doi: 10.2215/CJN.10191013. Epub 2014 Feb 27.</citation>
    <PMID>24578332</PMID>
  </results_reference>
  <results_reference>
    <citation>Damman K, van Deursen VM, Navis G, Voors AA, van Veldhuisen DJ, Hillege HL. Increased central venous pressure is associated with impaired renal function and mortality in a broad spectrum of patients with cardiovascular disease. J Am Coll Cardiol. 2009 Feb 17;53(7):582-588. doi: 10.1016/j.jacc.2008.08.080.</citation>
    <PMID>19215832</PMID>
  </results_reference>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>January 29, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>December 14, 2020</last_update_submitted>
  <last_update_submitted_qc>December 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Giessen</investigator_affiliation>
    <investigator_full_name>Faeq Husain</investigator_full_name>
    <investigator_title>Senior Physician Nephrology</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All IPD that underlie results in a publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Starting 6 months after publication</ipd_time_frame>
  </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/NCT03039972
org study id: AZ 239/16
nct id: NCT03039972
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Changes in renal function and body composition in patients with pulmonary hypertension
This prospective single-center study is designed to analyze changes in renal function and
      body composition in patients with suspected or pre-diagnosed pulmonary hypertension at
      pulmonary hypertension outpatient clinic, University Hospital Giessen and Marburg, Campus
      Giessen.
observational model: Cohort
time perspective: Prospective
measure: Changes in renal function in patients with pulmonary hypertension
time frame: 1 year
description: Estimated GFR based on Chronic Kidney Disease Epidemiology Collaboration-creatinine-cystatin C will be used to determine renal function at baseline and at 1 year follow-up
measure: Changes in hydration status in patients with pulmonary hypertension
time frame: 1 year
description: Bioimpedance analysis will be used to determine hydration status at baseline and at 1 year follow-up
measure: Changes in nutritional status in patients with pulmonary hypertension
time frame: 1 year
description: Bioimpedance analysis will be used to determine lean tissue and fat mass at baseline and at 1 year follow-up
measure: Prognostic value of baseline renal function, hydration and nutritional status on pulmonary hypertension-associated morbidity and mortality
time frame: 1 year
description: pulmonary hypertension-associated morbidity and mortality (defined as escalation of pulmonary hypertension-specific therapy, unscheduled hospitalization and all-cause mortality) will be prospectively assessed during follow-up period
arm group label: Pulmonary Hypertension
description: Adult outpatients with suspected or prediagnosed pulmonary hypertension irrespective of subclass and all chronic kidney disease stages
intervention type: Diagnostic Test
intervention name: No intervention
description: No intervention
arm group label: Pulmonary Hypertension
Collection of only residual material (blood, urine) for Deutsche Zentrum für Lungenforschung
      Biobank.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Werner Seeger, MD
role: Study Director
affiliation: Department of Internal Medicine II, Division of Pulmonology, Nephrology and Critical Care Medicine
facility: 
country: Germany
citation: Bellomo R, Prowle JR, Echeverri JE. Diuretic therapy in fluid-overloaded and heart failure patients. Contrib Nephrol. 2010;164:153-163. doi: 10.1159/000313728. Epub 2010 Apr 20.
PMID: 20428001
citation: Ronco C, Verger C, Crepaldi C, Pham J, De Los Rios T, Gauly A, Wabel P, Van Biesen W; IPOD-PD Study Group. Baseline hydration status in incident peritoneal dialysis patients: the initiative of patient outcomes in dialysis (IPOD-PD study)dagger. Nephrol Dial Transplant. 2015 May;30(5):849-58. doi: 10.1093/ndt/gfv013. Epub 2015 Mar 11.
PMID: 25762355
citation: Navaneethan SD, Wehbe E, Heresi GA, Gaur V, Minai OA, Arrigain S, Nally JV Jr, Schold JD, Rahman M, Dweik RA. Presence and outcomes of kidney disease in patients with pulmonary hypertension. Clin J Am Soc Nephrol. 2014 May;9(5):855-63. doi: 10.2215/CJN.10191013. Epub 2014 Feb 27.
PMID: 24578332
citation: Damman K, van Deursen VM, Navis G, Voors AA, van Veldhuisen DJ, Hillege HL. Increased central venous pressure is associated with impaired renal function and mortality in a broad spectrum of patients with cardiovascular disease. J Am Coll Cardiol. 2009 Feb 17;53(7):582-588. doi: 10.1016/j.jacc.2008.08.080.
PMID: 19215832
responsible party type: Principal Investigator
investigator affiliation: University of Giessen
investigator full name: Faeq Husain
investigator title: Senior Physician Nephrology
mesh term: Hypertension, Pulmonary
mesh term: Hypertension
sharing ipd: Yes
ipd description: All IPD that underlie results in a publication
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: Starting 6 months after publication