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

University of Aarhus

Status and phase: Enrolling; Phase 1

Conditions: Acute Heart Failure

Treatments: Dietary Supplement: HVMN Ketone Ester; Dietary Supplement: Maltodextrin

Study type: Interventional

Funder types: Other

Identifiers

NCT04442555

KETO-AHF1 1-10-72-59-19

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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12 participants in 2 patient groups, including a placebo group

3-Hydroxybutyrate treatment

Experimental group

Description:

HVMN Ketone Ester 0,5 g / kg

Treatment:

Dietary Supplement: HVMN Ketone Ester

Placebo Treatment

Placebo Comparator group

Description:

Maltodextrin-base isocaloric placebo

Treatment:

Dietary Supplement: Maltodextrin