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

Phase 1

• Conditions: Acute Heart Failure
• Interventions: Dietary Supplement: HVMN Ketone Ester; Dietary Supplement: Maltodextrin

• Registration Number: NCT04442555
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2020-06-18
• Study First Submitted QC: 2020-06-18
• Study First Posted: 2020-06-22
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-14
• Last Update Posted: 2022-07-18
• Primary Completion: 2023-03-30
• Study Completion: 2023-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 12

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
3-Hydroxybutyrate treatment	HVMN Ketone Ester	HVMN Ketone Ester 0,5 g / kg
Placebo Treatment	Maltodextrin	Maltodextrin-base isocaloric placebo

Primary Outcome Measures

Name	Time	Method
Cardiac Output (L/min)	3 hours - Area under the curve	Right Heart Catherization
Left Ventricular Ejection Fraction	3 hours - Area under the curve	Echocardiography

Secondary Outcome Measures

Name	Time	Method
Left Ventricular Outflow Tract Velocity Time Integral (cm)	3 hours - Area under the curve	Echocardiography
Left Ventricular Filling Pressure (mmHg)	3 hours - Area under the curve	Right Heart Catherization

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark