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

NCT04442555 | Unknown Phase 1 DMC

• 1 other identifier: KETO-AHF1 1-10-72-59-19
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Cardiac Output (L/min)

  Right Heart Catherization

  3 hours - Area under the curve

• Left Ventricular Ejection Fraction

  Echocardiography

  3 hours - Area under the curve

Secondary Outcomes (2)

• Left Ventricular Outflow Tract Velocity Time Integral (cm)

  3 hours - Area under the curve

• Left Ventricular Filling Pressure (mmHg)

  3 hours - Area under the curve

Study Arms (2)

3-Hydroxybutyrate treatment

EXPERIMENTAL

HVMN Ketone Ester 0,5 g / kg

Dietary Supplement: HVMN Ketone Ester

Placebo Treatment

PLACEBO COMPARATOR

Maltodextrin-base isocaloric placebo

Dietary Supplement: Maltodextrin

Interventions

HVMN Ketone Ester DIETARY_SUPPLEMENT

Commercially available ketone supplement

3-Hydroxybutyrate treatment

Maltodextrin DIETARY_SUPPLEMENT

Commercially available maltodextrin supplement

Placebo Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

MeSH Terms

Interventions

maltodextrin

Central Study Contacts

Kristian H Christensen, MD

CONTACT

26603577; kristianhylleberg@gmail.com

Henrik S Wiggers, DMsci

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: June 22, 2020
• Study Start: February 1, 2020
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: July 18, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)