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

Primary Purpose

Acute Heart Failure

Status
Recruiting
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
HVMN Ketone Ester
Maltodextrin
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Aarhus University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

3-Hydroxybutyrate treatment

Placebo Treatment

Arm Description

HVMN Ketone Ester 0,5 g / kg

Maltodextrin-base isocaloric placebo

Outcomes

Primary Outcome Measures

Cardiac Output (L/min)
Right Heart Catherization
Left Ventricular Ejection Fraction
Echocardiography

Secondary Outcome Measures

Left Ventricular Outflow Tract Velocity Time Integral (cm)
Echocardiography
Left Ventricular Filling Pressure (mmHg)
Right Heart Catherization

Full Information

First Posted
June 18, 2020
Last Updated
July 14, 2022
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT04442555
Brief Title
Treatment With the Ketone Body 3-hydroxybutyrate in Patients With Acute Heart Failure
Acronym
KETO-AHF1
Official Title
Treatment With the Ketone Body 3-hydroxybutyrate in Patients With Acute Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
March 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
3-Hydroxybutyrate treatment
Arm Type
Experimental
Arm Description
HVMN Ketone Ester 0,5 g / kg
Arm Title
Placebo Treatment
Arm Type
Placebo Comparator
Arm Description
Maltodextrin-base isocaloric placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
HVMN Ketone Ester
Intervention Description
Commercially available ketone supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Intervention Description
Commercially available maltodextrin supplement
Primary Outcome Measure Information:
Title
Cardiac Output (L/min)
Description
Right Heart Catherization
Time Frame
3 hours - Area under the curve
Title
Left Ventricular Ejection Fraction
Description
Echocardiography
Time Frame
3 hours - Area under the curve
Secondary Outcome Measure Information:
Title
Left Ventricular Outflow Tract Velocity Time Integral (cm)
Description
Echocardiography
Time Frame
3 hours - Area under the curve
Title
Left Ventricular Filling Pressure (mmHg)
Description
Right Heart Catherization
Time Frame
3 hours - Area under the curve

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristian H Christensen, MD
Phone
26603577
Email
kristianhylleberg@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Henrik S Wiggers, DMsci
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristian H Christensen, MD
Email
krstchri@rm.dk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Treatment With the Ketone Body 3-hydroxybutyrate in Patients With Acute Heart Failure

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