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

Sponsor
University of Aarhus (Other)
Overall Status
Recruiting
CT.gov ID
NCT04442555
Collaborator
(none)
12
1
2
37.9
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: HVMN Ketone Ester
  • Dietary Supplement: Maltodextrin
Phase 1

Study Design

Study Type:
Interventional
Anticipated 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 :
Feb 1, 2020
Anticipated Primary Completion Date :
Mar 30, 2023
Anticipated Study Completion Date :
Mar 30, 2023

Arms and Interventions

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

Primary Outcome Measures

  1. Cardiac Output (L/min) [3 hours - Area under the curve]

    Right Heart Catherization

  2. Left Ventricular Ejection Fraction [3 hours - Area under the curve]

    Echocardiography

Secondary Outcome Measures

  1. Left Ventricular Outflow Tract Velocity Time Integral (cm) [3 hours - Area under the curve]

    Echocardiography

  2. Left Ventricular Filling Pressure (mmHg) [3 hours - Area under the curve]

    Right Heart Catherization

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Aarhus University Hospital Aarhus Denmark 8200

Sponsors and Collaborators

  • University of Aarhus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Jun 22, 2020
Last Update Posted:
Jul 18, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 18, 2022