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

NCT ID: NCT04442555

Last Updated: 2022-07-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2023-03-30

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.

Conditions

Acute Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

3-Hydroxybutyrate treatment

HVMN Ketone Ester 0,5 g / kg

Group Type: EXPERIMENTAL

HVMN Ketone Ester

Intervention Type: DIETARY_SUPPLEMENT

Commercially available ketone supplement

Placebo Treatment

Maltodextrin-base isocaloric placebo

Group Type: PLACEBO_COMPARATOR

Maltodextrin

Intervention Type: DIETARY_SUPPLEMENT

Commercially available maltodextrin supplement

Interventions

HVMN Ketone Ester

Commercially available ketone supplement

Intervention Type: DIETARY_SUPPLEMENT

Maltodextrin

Commercially available maltodextrin supplement

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Kristian Hylleberg Christensen

MD, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Aarhus University Hospital

Aarhus, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Kristian H Christensen, MD

Role: CONTACT

kristianhylleberg@gmail.com

26603577

Henrik S Wiggers, DMsci

Role: CONTACT

Facility Contacts

Kristian H Christensen, MD

Role: primary

krstchri@rm.dk

Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id