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Treatment With the Ketone Body 3-hydroxybutyrate in Patients With Acute Heart Failure (KETO-AHF1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04442555
Recruitment Status : Recruiting
First Posted : June 22, 2020
Last Update Posted : July 18, 2022
Sponsor:
Information provided by (Responsible Party):
Kristian Hylleberg Christensen, University of Aarhus

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Acute Heart Failure Dietary Supplement: HVMN Ketone Ester Dietary Supplement: Maltodextrin Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Treatment With the Ketone Body 3-hydroxybutyrate in Patients With Acute Heart Failure
Actual Study Start Date : February 1, 2020
Estimated Primary Completion Date : March 30, 2023
Estimated Study Completion Date : March 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
Experimental: 3-Hydroxybutyrate treatment
HVMN Ketone Ester 0,5 g / kg
 Dietary Supplement: HVMN Ketone Ester
Commercially available ketone supplement
Placebo Comparator: Placebo Treatment
Maltodextrin-base isocaloric placebo
 Dietary Supplement: Maltodextrin
Commercially available maltodextrin supplement


Outcome Measures
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Primary Outcome Measures :
  1. Cardiac Output (L/min) [ Time Frame: 3 hours - Area under the curve ]
    Right Heart Catherization

  2. Left Ventricular Ejection Fraction [ Time Frame: 3 hours - Area under the curve ]
    Echocardiography


Secondary Outcome Measures :
  1. Left Ventricular Outflow Tract Velocity Time Integral (cm) [ Time Frame: 3 hours - Area under the curve ]
    Echocardiography

  2. Left Ventricular Filling Pressure (mmHg) [ Time Frame: 3 hours - Area under the curve ]
    Right Heart Catherization


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hospitalized with worsening HF or de novo diagnosis of HF
  • LVEF < 50%
  • Treatment with intravenous loop diuretics during the hospitalization and/or increased dosage of oral diuretics.

Exclusion Criteria:

  • Cardiogenic shock
  • Systolic Blood Pressure <85 mmHg
  • Acute myocardial infarction other than type II <5 days prior to randomization *
  • Severe uncorrected cardiac valve disease
  • Expected or possible need for hemodialysis as judged by the investigator
  • Ongoing inotropic treatment
  • Possible need for advanced heart failure treatment (LVAD, heart transplantation) as judged by the investigator.
  • Ongoing, severe infection
  • Severe respiratory distress (SAT<90% or RF> 24/min or receiving more than 2 l O2/min or intubated)
  • Atrial Fibrillation with heart >120 beats per minute

  • Inability to cooperate to or accept oral intake of food, including presence of major gastrointestinal discomfort.

    • If suspected or confirmed acute myocardial infarction as cause of acute heart failure, patients can be recruited 5 days after hospitalization in the absence of malignant arrhythmias (e.g. ventricular tachycardia) or clinically significant residual angina pectoris.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04442555


Contacts
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Contact: Kristian H Christensen, MD 26603577 kristianhylleberg@gmail.com
Contact: Henrik S Wiggers, DMsci

Locations
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Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8200
Contact: Kristian H Christensen, MD       krstchri@rm.dk   
Sponsors and Collaborators
University of Aarhus
More Information
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Responsible Party: Kristian Hylleberg Christensen, MD, Principal Investigator, University of Aarhus
ClinicalTrials.gov Identifier: NCT04442555    
Other Study ID Numbers: KETO-AHF1 1-10-72-59-19
First Posted: June 22, 2020    Key Record Dates
Last Update Posted: July 18, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases