<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/NCT04455477</url>
  </required_header>
  <id_info>
    <org_study_id>B2020-056R</org_study_id>
    <nct_id>NCT04455477</nct_id>
  </id_info>
  <brief_title>Nesiritide for Ventilated Congestive Heart Failure</brief_title>
  <acronym>HENCHF</acronym>
  <official_title>Hemodynamic Effects of Nesiritide on Congestive Heart Failure Patients Receiving Mechanical Ventilation: A Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Zhongshan Hospital</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>
      The congestive heart failure is a common disease among patients who receive cardiac surgery&#xD;
      and may lead to prolonged ventilation support. Nesiritide was a potential therapy for&#xD;
      congestive heart failure. This study aimed to compare the Nesiritide induced hemodynamical&#xD;
      status changes among congestive heart failure patients with invasive ventilation support.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 14, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</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>Changes of cardiac output</measure>
    <time_frame>Before and 30-min after using a standard dose of Nesiritide</time_frame>
    <description>Changes of cardiac output measured by hemodynamical monitoring tools</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of systemic filling pressure</measure>
    <time_frame>Before and 30-min after using a standard dose of Nesiritide</time_frame>
    <description>Changes of the intercept of regression line of paired VR-RAP points at different PEEP levels.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes of cardiac function curve</measure>
    <time_frame>Before and 30-min after using a standard dose of Nesiritide</time_frame>
    <description>Using body position changes (±15°) to simulate the change of preload, and therefore depicte the Starling curve</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of venous return curve</measure>
    <time_frame>Before and 30-min after using a standard dose of Nesiritide</time_frame>
    <description>Changes of venous return curve depicted by different PEEP setting</description>
  </secondary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Congestive Heart Failure</condition>
  <condition>Mechanical Ventilation</condition>
  <condition>Using Nesiritide</condition>
  <condition>Venous Return</condition>
  <condition>Cardiac Function</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nesiritide</intervention_name>
    <description>The attending physicans decide whether to use Nesiritide for congestive heart failure patients. Only patients who will use Nesiritide are enrolled.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Congestive heart failure patients relying on mechanical ventilation and therefore decide to&#xD;
        try the Nesiritide.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age≥18 years；&#xD;
&#xD;
          -  Congestive Heart Failure;&#xD;
&#xD;
          -  With mechanical ventilation；&#xD;
&#xD;
          -  With hemodynamic monitoring devices;&#xD;
&#xD;
          -  The physicians made the decision of using Nesiritide.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unstable hemodynamic status；&#xD;
&#xD;
          -  Severe renal dysfunction.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Zhe Luo, MD</last_name>
    <phone>+8613916127028</phone>
    <email>luo.zhe@zs-hospital.sh.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Zhongshan Hospital</name>
      <address>
        <city>Xuhui</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhe Luo</last_name>
      <phone>+8613916127028</phone>
      <email>luo.zhe@zs-hospital.sh.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>June 28, 2020</last_update_submitted>
  <last_update_submitted_qc>June 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Congestive Heart Failure</keyword>
  <keyword>Nesiritide</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Natriuretic Peptide, Brain</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Our institution did not approve this.</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/NCT04455477
org study id: B2020-056R
nct id: NCT04455477
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The congestive heart failure is a common disease among patients who receive cardiac surgery
      and may lead to prolonged ventilation support. Nesiritide was a potential therapy for
      congestive heart failure. This study aimed to compare the Nesiritide induced hemodynamical
      status changes among congestive heart failure patients with invasive ventilation support.
observational model: Other
time perspective: Prospective
measure: Changes of cardiac output
time frame: Before and 30-min after using a standard dose of Nesiritide
description: Changes of cardiac output measured by hemodynamical monitoring tools
measure: Changes of systemic filling pressure
time frame: Before and 30-min after using a standard dose of Nesiritide
description: Changes of the intercept of regression line of paired VR-RAP points at different PEEP levels.
measure: Changes of cardiac function curve
time frame: Before and 30-min after using a standard dose of Nesiritide
description: Using body position changes (±15°) to simulate the change of preload, and therefore depicte the Starling curve
measure: Changes of venous return curve
time frame: Before and 30-min after using a standard dose of Nesiritide
description: Changes of venous return curve depicted by different PEEP setting
intervention type: Drug
intervention name: Nesiritide
description: The attending physicans decide whether to use Nesiritide for congestive heart failure patients. Only patients who will use Nesiritide are enrolled.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Zhe Luo, MD
phone: +8613916127028
email: luo.zhe@zs-hospital.sh.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Natriuretic Peptide, Brain
sharing ipd: No
ipd description: Our institution did not approve this.