<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/NCT03039959</url>
  </required_header>
  <id_info>
    <org_study_id>AZ 237/16</org_study_id>
    <nct_id>NCT03039959</nct_id>
  </id_info>
  <brief_title>Predictive Value of Renal Venous Flow Profiles for Adverse Outcomes in Right Heart Failure</brief_title>
  <official_title>Predictive Value of Renal Venous Flow Profiles for Adverse Outcomes in Right Heart Failure</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>
      Predictive value of renal venous flow profiles for adverse outcomes in patients with right&#xD;
      heart failure&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Persistent congestion with deteriorating renal function is an important cause of adverse&#xD;
      outcomes in heart failure. The investigators aimed to characterize new Doppler&#xD;
      ultrasonography approaches to evaluate the continuum of renal congestion. Pulmonary&#xD;
      hypertension is the most common precursor to right heart failure and thus represents an ideal&#xD;
      scenario to study congestion. The second cohort comprises consecutive Cardiology inpatients&#xD;
      aged ≥18 years with a new or pre-existing diagnosis of heart failure who are referred to the&#xD;
      consultant nephrologist with a history of diuretic-resistant fluid overload and impaired&#xD;
      renal function. The investigators choose patients with heart failure to broaden the findings&#xD;
      to the most common clinical entity of right ventricular failure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">March 30, 2018</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>18 Months</target_duration>
  <primary_outcome>
    <measure>Rate of pulmonary hypertension-related morbidity and all-cause mortality (pulmonary hypertension cohort)</measure>
    <time_frame>1 year post-discharge</time_frame>
    <description>Any hospitalization for worsening of pulmonary hypertension, lung transplantation, or need for escalation of pulmonary hypertension-specific therapy, and death from any cause</description>
  </primary_outcome>
  <primary_outcome>
    <measure>First occurrence of worsening heart failure and first occurrence of need for renal replacement therapy (heart failure cohort)</measure>
    <time_frame>1 year post-discharge</time_frame>
    <description>Unscheduled hospitalization or unscheduled office visit for heart failure and new onset renal replacement therapy</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">421</enrollment>
  <condition>Pulmonary Hypertension</condition>
  <condition>Cardiorenal Syndrome</condition>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Pulmonary hypertension cohort</arm_group_label>
    <description>Consecutive adult Pulmonology inpatients with suspected or pre-diagnosed pulmonary hypertension undergoing invasive right heart catheterization.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Heart failure cohort</arm_group_label>
    <description>Consecutive adult Cardiology inpatients with a new or pre-existing diagnosis of heart failure who are referred to the consultant nephrologist with a history of diuretic-resistant fluid overload and impaired renal function.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>No intervention</description>
    <arm_group_label>Heart failure cohort</arm_group_label>
    <arm_group_label>Pulmonary hypertension cohort</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Only residual material will be reserved for the Deutsche Zentrum für Lungenforschung Biobank&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive Pulmonology inpatients with suspected or pre-diagnosed pulmonary hypertension&#xD;
        undergoing right heart catheterization (pulmonary hypertension cohort) and consecutive&#xD;
        Cardiology inpatients who are referred to the consultant nephrologist with a history of&#xD;
        diuretic-resistant fluid overload and impaired renal function (heart failure cohort).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Pulmonary hypertension cohort:&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  CKD stage 5 (KDIGO)&#xD;
&#xD;
          -  pre-existing acute kidney injury (acute kidney injury was defined as an increase in&#xD;
             serum creatinine by ≥ 0.3 mg/dl within 48 hours or to ≥ 1.5 times baseline within the&#xD;
             prior 7 days, as determined by all available serum creatinine values from hospital and&#xD;
             outpatient medical records within the previous 90 days)&#xD;
&#xD;
          -  Non-end stage renal disease patients with extracorporeal or peritoneal ultrafiltration&#xD;
             for treatment of diuretic-resistant fluid overload&#xD;
&#xD;
          -  Patients with primary kidney disease (e.g., glomerulonephritis, autosomal dominant&#xD;
             polycystic kidney disease, postrenal obstruction)&#xD;
&#xD;
          -  solid-organ transplant recipients&#xD;
&#xD;
          -  use of non-steroidal inflammatory drugs within 72 hours before right heart&#xD;
             catheterization&#xD;
&#xD;
        Heart failure cohort:&#xD;
&#xD;
        Exclusion criteria same as in the discovery cohort except pre-existing acute kidney injury&#xD;
&#xD;
          -  Patients with mechanical assist devices are excluded&#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>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>
  <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>Iida N, Seo Y, Sai S, Machino-Ohtsuka T, Yamamoto M, Ishizu T, Kawakami Y, Aonuma K. Clinical Implications of Intrarenal Hemodynamic Evaluation by Doppler Ultrasonography in Heart Failure. JACC Heart Fail. 2016 Aug;4(8):674-82. doi: 10.1016/j.jchf.2016.03.016. Epub 2016 May 11.</citation>
    <PMID>27179835</PMID>
  </results_reference>
  <results_reference>
    <citation>Sugiura T, Wada A. Resistive index predicts renal prognosis in chronic kidney disease. Nephrol Dial Transplant. 2009 Sep;24(9):2780-5. doi: 10.1093/ndt/gfp121. Epub 2009 Mar 23.</citation>
    <PMID>19318356</PMID>
  </results_reference>
  <verification_date>February 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>February 16, 2020</last_update_submitted>
  <last_update_submitted_qc>February 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 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>
  <keyword>Renal Doppler ultrasonography</keyword>
  <keyword>Venous Congestion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension, Pulmonary</mesh_term>
    <mesh_term>Cardio-Renal Syndrome</mesh_term>
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03039959
org study id: AZ 237/16
nct id: NCT03039959
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Predictive value of renal venous flow profiles for adverse outcomes in patients with right
      heart failure
Persistent congestion with deteriorating renal function is an important cause of adverse
      outcomes in heart failure. The investigators aimed to characterize new Doppler
      ultrasonography approaches to evaluate the continuum of renal congestion. Pulmonary
      hypertension is the most common precursor to right heart failure and thus represents an ideal
      scenario to study congestion. The second cohort comprises consecutive Cardiology inpatients
      aged ≥18 years with a new or pre-existing diagnosis of heart failure who are referred to the
      consultant nephrologist with a history of diuretic-resistant fluid overload and impaired
      renal function. The investigators choose patients with heart failure to broaden the findings
      to the most common clinical entity of right ventricular failure.
observational model: Cohort
time perspective: Prospective
measure: Rate of pulmonary hypertension-related morbidity and all-cause mortality (pulmonary hypertension cohort)
time frame: 1 year post-discharge
description: Any hospitalization for worsening of pulmonary hypertension, lung transplantation, or need for escalation of pulmonary hypertension-specific therapy, and death from any cause
measure: First occurrence of worsening heart failure and first occurrence of need for renal replacement therapy (heart failure cohort)
time frame: 1 year post-discharge
description: Unscheduled hospitalization or unscheduled office visit for heart failure and new onset renal replacement therapy
arm group label: Pulmonary hypertension cohort
description: Consecutive adult Pulmonology inpatients with suspected or pre-diagnosed pulmonary hypertension undergoing invasive right heart catheterization.
arm group label: Heart failure cohort
description: Consecutive adult Cardiology inpatients with a new or pre-existing diagnosis of heart failure who are referred to the consultant nephrologist with a history of diuretic-resistant fluid overload and impaired renal function.
intervention type: Diagnostic Test
intervention name: No intervention
description: No intervention
arm group label: Heart failure cohort
arm group label: Pulmonary hypertension cohort
Only residual material will be reserved for the Deutsche Zentrum für Lungenforschung Biobank
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
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: 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: Iida N, Seo Y, Sai S, Machino-Ohtsuka T, Yamamoto M, Ishizu T, Kawakami Y, Aonuma K. Clinical Implications of Intrarenal Hemodynamic Evaluation by Doppler Ultrasonography in Heart Failure. JACC Heart Fail. 2016 Aug;4(8):674-82. doi: 10.1016/j.jchf.2016.03.016. Epub 2016 May 11.
PMID: 27179835
citation: Sugiura T, Wada A. Resistive index predicts renal prognosis in chronic kidney disease. Nephrol Dial Transplant. 2009 Sep;24(9):2780-5. doi: 10.1093/ndt/gfp121. Epub 2009 Mar 23.
PMID: 19318356
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: Cardio-Renal Syndrome
mesh term: Heart Failure
sharing ipd: Undecided