<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/NCT02973620</url>
  </required_header>
  <id_info>
    <org_study_id>TNX-LVO-02</org_study_id>
    <nct_id>NCT02973620</nct_id>
  </id_info>
  <brief_title>Levosimendan Compassionate Use in Pediatric Patients With Advanced Decompensated Heart Failure</brief_title>
  <official_title>Expanded Access Protocol; Intermediate Size Protocol: Levosimendan Compassionate Use in Pediatric Patients With Advanced Decompensated Heart Failure Who Are Refractory to Standard Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tenax Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tenax Therapeutics, Inc.</source>
  <brief_summary>
    <textblock>
      Open label study of levosimendan; planned comparison for effectiveness and safety to historic&#xD;
      matched case controls from participating sites.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>No longer available</overall_status>
  <study_type>Expanded Access</study_type>
  <condition>Heart Decompensation</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levosimendan</intervention_name>
    <description>levosimendan infusion started at 0.1 mcg/kg/min for 6-12 hours, increased to 0.2 mcg/kg/min for 24-36 hours</description>
    <other_name>Simdax</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        General Eligibility&#xD;
&#xD;
        All patients must meet at least one of the following definitions of failed standard therapy&#xD;
        of decompensated heart failure:&#xD;
&#xD;
        Definition for failure of standard therapy:&#xD;
&#xD;
          1. Decompensated heart failure refractory to standard therapy (Milrinone of&#xD;
             ≥0.5mcg/kg/min for &gt;48 hours with EF &lt;35%) including any of the following:&#xD;
&#xD;
               -  (SaO2 - SmVO2) &gt; 30 % or lactate &gt;3 AND/OR&#xD;
&#xD;
               -  Need for second inotropic agent AND/OR&#xD;
&#xD;
               -  Need for positive pressure ventilation AND&#xD;
&#xD;
               -  Patient not qualifying for long term ventricular assist device support or&#xD;
                  transplant at the time of assessment.&#xD;
&#xD;
          2. Cardiogenic shock with acute decompensated heart failure (requiring positive pressure&#xD;
             ventilation and addition of inotropic support with or without use of Milrinone with EF&#xD;
             &lt;35%) refractory to therapy for more than 48h including any or all of the following:&#xD;
&#xD;
               -  (SaO2 - SmVO2) &gt; 30 % or lactate &gt;3&#xD;
&#xD;
               -  Patient not qualifying for long term ventricular assist device support or&#xD;
                  transplant at the time of assessment.&#xD;
&#xD;
               -  Potential need for short-term mechanical circulatory support.&#xD;
&#xD;
          3. Failure to wean off ECMO support with use of standard inotropic / vasoconstrictor&#xD;
             support.&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female, ≤18 years of age with acute or acute on chronic decompensated heart&#xD;
             failure.&#xD;
&#xD;
          2. Male or female, ≤18 years of age on ECMO support and unable to wean from ECMO support.&#xD;
&#xD;
          3. Informed Consent signed by the subject's parents or their legally acceptable&#xD;
             representatives indicating that they understand the purpose of and procedures required&#xD;
             for expanded access and are willing to participate in the study.&#xD;
&#xD;
          4. Patients meeting one of the following definitions of failed standard therapy of&#xD;
             decompensated heart failure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients &lt; 36 weeks gestational age&#xD;
&#xD;
          2. Patients weighing &lt; 2 kg&#xD;
&#xD;
          3. Obstructive cardiomyopathy, constrictive pericarditis, pericardial tamponade&#xD;
&#xD;
          4. Estimated glomerular filtration rate (eGRF) &lt; 30 mL/min/1.73m2.&#xD;
&#xD;
          5. Known allergic reaction or sensitivity to levosimendan or excipients.&#xD;
&#xD;
          6. A history of Torsades de Pointes, uncorrectable hypo- or hyperkalemia, uncorrectable&#xD;
             hypo- or hypercalcemia&#xD;
&#xD;
          7. Pregnant, suspected to be pregnant, or breast-feeding.&#xD;
&#xD;
          8. Inability or unwillingness of subject or legal guardian/representative to give written&#xD;
             informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
  </eligibility>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>May 10, 2018</last_update_submitted>
  <last_update_submitted_qc>May 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>Simendan</mesh_term>
  </intervention_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/NCT02973620
org study id: TNX-LVO-02
nct id: NCT02973620
lead sponsor: 
Open label study of levosimendan; planned comparison for effectiveness and safety to historic
      matched case controls from participating sites.
intervention type: Drug
intervention name: Levosimendan
description: levosimendan infusion started at 0.1 mcg/kg/min for 6-12 hours, increased to 0.2 mcg/kg/min for 24-36 hours
other name: Simdax
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
country: United States
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Simendan