xml: <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/NCT06024889</url>
    </required_header>
    <id_info>
      <org_study_id>H-23029822</org_study_id>
      <nct_id>NCT06024889</nct_id>
    </id_info>
    <brief_title>Acute Effects of Furosemide on Hemodynamics and Pulmonary Congestion in Acute Decompensated Heart Failure.</brief_title>
    <official_title>Acute Effects of Furosemide on Hemodynamics and Pulmonary Congestion in Acute Decompensated Heart Failure.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Johannes Grand</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Copenhagen University Hospital, Hvidovre</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Intravenous (IV) loop diuretics have been a key component in treating pulmonary edema since&#xD;
        the 1960s and has a Class 1 recommendation in the 2021 guidelines for acute heart failure.&#xD;
        However, no randomized clinical trials have investigated loop diuretics versus other&#xD;
        interventions for acute heart failure, and clinical knowledge of the hemodynamic effects of&#xD;
        furosemide is based in studies from the 1970s. In this study, we aim to assess the acute&#xD;
        effect of furosemide on cardiac filling pressures and pulmonary congestion.&#xD;
  &#xD;
        Hypothesis:&#xD;
  &#xD;
        Administration of furosemide induces a hyperacute (within 30 minutes) lowering of cardiac&#xD;
        filling pressures and pulmonary congestion before significant diuresis occurs.&#xD;
  &#xD;
        Design:&#xD;
  &#xD;
        A prospective, interventional study including 20 patients admitted due to a clinical&#xD;
        diagnosis of acute heart failure with pulmonary congestion.&#xD;
  &#xD;
        Intervention:&#xD;
  &#xD;
        80 mg of furosemide is administered IV. Measurements include blood pressure, peripheral&#xD;
        oxygen saturation, pulmonary fluid content by ReDS*, ultrasound examination of heart and&#xD;
        lungs, and assessment of cardiac filling pressures with doppler and strain analysis.&#xD;
        Measurements are repeated at several time points until 6 hours have passed.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Prospective observational study of the acute and subacute effects of furosemide in patients&#xD;
        with acute heart failure.&#xD;
  &#xD;
        After inclusion, 80 mg of furosemide is administered IV.&#xD;
  &#xD;
        Measurements include blood pressure, peripheral oxygen saturation, pulmonary fluid content,&#xD;
        ultrasound examination of heart and lungs, and assessment of cardiac filling pressures with&#xD;
        doppler and strain analysis. Measurements are repeated at several time points until 6 hours&#xD;
        have passed.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 22, 2023</start_date>
    <completion_date type="Anticipated">February 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 1, 2024</primary_completion_date>
    <phase>Phase 1/Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pulmonary fluid content</measure>
      <time_frame>From the time 0 to 30 minutes</time_frame>
      <description>Remote dielectric sensing (ReDS) is a non-invasive electromagnetic-based tool that measures absolute lung fluid content and gives the fluid content in a proportional value ranging from 0-100 percent. 20-35% represent normal values.&#xD;
  The primary outcome will be change in pulmonary fluid content after administration of furosemide</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Acute Heart Failure</condition>
    <arm_group>
      <arm_group_label>Furosemide</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>80 mg of furosemide is administered IV</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Furosemide Injection</intervention_name>
      <description>Intravenous administration of 80 mg furosemide is followed by assessing blood pressure, peripheral oxygen saturation, pulmonary fluid content by ReDS*, and ultrasound examination of heart and lungs, including assessment of filling pressures with doppler and strain analysis. These measurements are repeated at multiple time points until 6 hours have elapsed.</description>
      <arm_group_label>Furosemide</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age ≥ 18 years&#xD;
  &#xD;
            2. Clinical diagnosis of acute heart failure requiring hospitalization&#xD;
  &#xD;
            3. Systolic blood pressure ≥100 mmHg&#xD;
  &#xD;
            4. Oxygen saturation &lt;94% or need of oxygen&#xD;
  &#xD;
            5. Confirmed pulmonary congestion on x-ray or ReDS&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. More than 40 mg iv furosemide within the last three hours before randomization,&#xD;
               including prehospital administration&#xD;
  &#xD;
            2. Ongoing ventricular taky- or brady-arrythmias or supraventricular arrhythmias with HR&#xD;
               &gt; 180 or &lt; 40 bpm.&#xD;
  &#xD;
            3. Known chronic obstructive lung disease&#xD;
  &#xD;
            4. Pacemaker or ICD on the right side&#xD;
  &#xD;
            5. Congenital heart malformations or intra-thoracic mass that would affect the right lung&#xD;
               anatomy (e.g. dextrocardia, lung carcinoma)&#xD;
  &#xD;
            6. Wounds, burns, healing tissue, skin infection or recent skin graft or flap where the&#xD;
               sensors should be attached to the skin&#xD;
  &#xD;
            7. Height less than 155 cm or higher than 200 cm&#xD;
  &#xD;
            8. BMI of less than 18 or more than 38&#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>Johannes Grand</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Cardiology</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Johannes Grand</last_name>
      <phone>+4538623862</phone>
      <email>johannes.grand@regionh.dk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Nora Chaidi</last_name>
      <phone>+4538623862</phone>
      <email>nora.el.caidi@regionh.dk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Amager-Hvidovre Hospital</name>
        <address>
          <city>Copenhagen</city>
          <state>Capital Region Of Denmark</state>
          <zip>2650</zip>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Johannes Grand, MD, PhD, MPH</last_name>
        <email>johannes.grand@regionh.dk</email>
      </contact>
      <contact_backup>
        <last_name>Nora Caidi</last_name>
        <email>nora.el.caidi@regionh.dk</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Copenhagen University Hospital, Hvidovre</investigator_affiliation>
      <investigator_full_name>Johannes Grand</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <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>Furosemide</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06024889
  org study id: H-23029822
  nct id: NCT06024889
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Intravenous (IV) loop diuretics have been a key component in treating pulmonary edema since
        the 1960s and has a Class 1 recommendation in the 2021 guidelines for acute heart failure.
        However, no randomized clinical trials have investigated loop diuretics versus other
        interventions for acute heart failure, and clinical knowledge of the hemodynamic effects of
        furosemide is based in studies from the 1970s. In this study, we aim to assess the acute
        effect of furosemide on cardiac filling pressures and pulmonary congestion.
  
        Hypothesis:
  
        Administration of furosemide induces a hyperacute (within 30 minutes) lowering of cardiac
        filling pressures and pulmonary congestion before significant diuresis occurs.
  
        Design:
  
        A prospective, interventional study including 20 patients admitted due to a clinical
        diagnosis of acute heart failure with pulmonary congestion.
  
        Intervention:
  
        80 mg of furosemide is administered IV. Measurements include blood pressure, peripheral
        oxygen saturation, pulmonary fluid content by ReDS*, ultrasound examination of heart and
        lungs, and assessment of cardiac filling pressures with doppler and strain analysis.
        Measurements are repeated at several time points until 6 hours have passed.
  Prospective observational study of the acute and subacute effects of furosemide in patients
        with acute heart failure.
  
        After inclusion, 80 mg of furosemide is administered IV.
  
        Measurements include blood pressure, peripheral oxygen saturation, pulmonary fluid content,
        ultrasound examination of heart and lungs, and assessment of cardiac filling pressures with
        doppler and strain analysis. Measurements are repeated at several time points until 6 hours
        have passed.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Pulmonary fluid content
  time frame: From the time 0 to 30 minutes
  description: Remote dielectric sensing (ReDS) is a non-invasive electromagnetic-based tool that measures absolute lung fluid content and gives the fluid content in a proportional value ranging from 0-100 percent. 20-35% represent normal values.
  The primary outcome will be change in pulmonary fluid content after administration of furosemide
  arm group label: Furosemide
  arm group type: Experimental
  description: 80 mg of furosemide is administered IV
  intervention type: Drug
  intervention name: Furosemide Injection
  description: Intravenous administration of 80 mg furosemide is followed by assessing blood pressure, peripheral oxygen saturation, pulmonary fluid content by ReDS*, and ultrasound examination of heart and lungs, including assessment of filling pressures with doppler and strain analysis. These measurements are repeated at multiple time points until 6 hours have elapsed.
  arm group label: Furosemide
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Johannes Grand
  role: Principal Investigator
  affiliation: Department of Cardiology
  last name: Johannes Grand
  phone: +4538623862
  email: johannes.grand@regionh.dk
  last name: Nora Chaidi
  phone: +4538623862
  email: nora.el.caidi@regionh.dk
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Denmark
  responsible party type: Sponsor-Investigator
  investigator affiliation: Copenhagen University Hospital, Hvidovre
  investigator full name: Johannes Grand
  investigator title: Principal Investigator
  mesh term: Heart Failure
  mesh term: Furosemide
  sharing ipd: No