<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/NCT04442555</url>
  </required_header>
  <id_info>
    <org_study_id>KETO-AHF1 1-10-72-59-19</org_study_id>
    <nct_id>NCT04442555</nct_id>
  </id_info>
  <brief_title>Treatment With the Ketone Body 3-hydroxybutyrate in Patients With Acute Heart Failure</brief_title>
  <acronym>KETO-AHF1</acronym>
  <official_title>Treatment With the Ketone Body 3-hydroxybutyrate in Patients With Acute Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Background:&#xD;
&#xD;
      Acute heart failure is a potentially life-threatening condition, reaching mortality rates of&#xD;
      up to 50% in advanced cases. The investigators have shown that infusion of ketone bodies&#xD;
      increase cardiac output by 40% in stabile patients with chronic heart failure. However, there&#xD;
      are no data showing the effects of ketone on patients with acute heart failure&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      To investigate the effect of ketone supplementation in patients with acute heart failure and&#xD;
      cardiogenic shock, using two different types of oral ketone supplements.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      The investigators will conduct four randomized placebo-controlled studies, to investigate the&#xD;
      hemodynamic effect of exogenous ketones in acute heart failure and cardiogenic shock.&#xD;
&#xD;
      Perspectives:&#xD;
&#xD;
      The present study will determine the potential beneficial effects of ketone supplements in&#xD;
      patients with acute heart failure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 1, 2020</start_date>
  <completion_date type="Anticipated">March 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">March 30, 2023</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiac Output (L/min)</measure>
    <time_frame>3 hours - Area under the curve</time_frame>
    <description>Right Heart Catherization</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Left Ventricular Ejection Fraction</measure>
    <time_frame>3 hours - Area under the curve</time_frame>
    <description>Echocardiography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Left Ventricular Outflow Tract Velocity Time Integral (cm)</measure>
    <time_frame>3 hours - Area under the curve</time_frame>
    <description>Echocardiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Ventricular Filling Pressure (mmHg)</measure>
    <time_frame>3 hours - Area under the curve</time_frame>
    <description>Right Heart Catherization</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Acute Heart Failure</condition>
  <arm_group>
    <arm_group_label>3-Hydroxybutyrate treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HVMN Ketone Ester 0,5 g / kg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Treatment</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Maltodextrin-base isocaloric placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>HVMN Ketone Ester</intervention_name>
    <description>Commercially available ketone supplement</description>
    <arm_group_label>3-Hydroxybutyrate treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Maltodextrin</intervention_name>
    <description>Commercially available maltodextrin supplement</description>
    <arm_group_label>Placebo Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hospitalized with worsening HF or de novo diagnosis of HF&#xD;
&#xD;
          -  LVEF &lt; 50%&#xD;
&#xD;
          -  Treatment with intravenous loop diuretics during the hospitalization and/or increased&#xD;
             dosage of oral diuretics.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiogenic shock&#xD;
&#xD;
          -  Systolic Blood Pressure &lt;85 mmHg&#xD;
&#xD;
          -  Acute myocardial infarction other than type II &lt;5 days prior to randomization *&#xD;
&#xD;
          -  Severe uncorrected cardiac valve disease&#xD;
&#xD;
          -  Expected or possible need for hemodialysis as judged by the investigator&#xD;
&#xD;
          -  Ongoing inotropic treatment&#xD;
&#xD;
          -  Possible need for advanced heart failure treatment (LVAD, heart transplantation) as&#xD;
             judged by the investigator.&#xD;
&#xD;
          -  Ongoing, severe infection&#xD;
&#xD;
          -  Severe respiratory distress (SAT&lt;90% or RF&gt; 24/min or receiving more than 2 l O2/min&#xD;
             or intubated)&#xD;
&#xD;
          -  Atrial Fibrillation with heart &gt;120 beats per minute&#xD;
&#xD;
          -  Inability to cooperate to or accept oral intake of food, including presence of major&#xD;
             gastrointestinal discomfort.&#xD;
&#xD;
               -  If suspected or confirmed acute myocardial infarction as cause of acute heart&#xD;
                  failure, patients can be recruited 5 days after hospitalization in the absence of&#xD;
                  malignant arrhythmias (e.g. ventricular tachycardia) or clinically significant&#xD;
                  residual angina pectoris.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Kristian H Christensen, MD</last_name>
    <phone>26603577</phone>
    <email>kristianhylleberg@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Henrik S Wiggers, DMsci</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kristian H Christensen, MD</last_name>
      <email>krstchri@rm.dk</email>
    </contact>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>July 14, 2022</last_update_submitted>
  <last_update_submitted_qc>July 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Aarhus</investigator_affiliation>
    <investigator_full_name>Kristian Hylleberg Christensen</investigator_full_name>
    <investigator_title>MD, 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>
  <patient_data>
    <sharing_ipd>No</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/NCT04442555
org study id: KETO-AHF1 1-10-72-59-19
nct id: NCT04442555
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Background:

      Acute heart failure is a potentially life-threatening condition, reaching mortality rates of
      up to 50% in advanced cases. The investigators have shown that infusion of ketone bodies
      increase cardiac output by 40% in stabile patients with chronic heart failure. However, there
      are no data showing the effects of ketone on patients with acute heart failure

      Objectives:

      To investigate the effect of ketone supplementation in patients with acute heart failure and
      cardiogenic shock, using two different types of oral ketone supplements.

      Methods:

      The investigators will conduct four randomized placebo-controlled studies, to investigate the
      hemodynamic effect of exogenous ketones in acute heart failure and cardiogenic shock.

      Perspectives:

      The present study will determine the potential beneficial effects of ketone supplements in
      patients with acute heart failure.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Cardiac Output (L/min)
time frame: 3 hours - Area under the curve
description: Right Heart Catherization
measure: Left Ventricular Ejection Fraction
time frame: 3 hours - Area under the curve
description: Echocardiography
measure: Left Ventricular Outflow Tract Velocity Time Integral (cm)
time frame: 3 hours - Area under the curve
description: Echocardiography
measure: Left Ventricular Filling Pressure (mmHg)
time frame: 3 hours - Area under the curve
description: Right Heart Catherization
arm group label: 3-Hydroxybutyrate treatment
arm group type: Experimental
description: HVMN Ketone Ester 0,5 g / kg
arm group label: Placebo Treatment
arm group type: Placebo Comparator
description: Maltodextrin-base isocaloric placebo
intervention type: Dietary Supplement
intervention name: HVMN Ketone Ester
description: Commercially available ketone supplement
arm group label: 3-Hydroxybutyrate treatment
intervention type: Dietary Supplement
intervention name: Maltodextrin
description: Commercially available maltodextrin supplement
arm group label: Placebo Treatment
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kristian H Christensen, MD
phone: 26603577
email: kristianhylleberg@gmail.com
last name: Henrik S Wiggers, DMsci
facility: 
status: Recruiting
contact: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University of Aarhus
investigator full name: Kristian Hylleberg Christensen
investigator title: MD, Principal Investigator
mesh term: Heart Failure
sharing ipd: No