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

Acute Heart Failure Clinical Trial

— KETO-AHF1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04442555
• Other study ID #: KETO-AHF1 1-10-72-59-19
• Status: Recruiting
• Phase: Phase 1
• Start date: February 1, 2020
• Est. completion date: March 30, 2023

Study information

• Verified date: July 2022
• Source: University of Aarhus
• Contact: Kristian H Christensen, MD
• Phone: 26603577
• Email: kristianhylleberg[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: March 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

Intervention

Dietary Supplement:
• HVMN Ketone Ester
Commercially available ketone supplement
• Maltodextrin
Commercially available maltodextrin supplement

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac Output (L/min)	Right Heart Catherization	3 hours - Area under the curve
Primary	Left Ventricular Ejection Fraction	Echocardiography	3 hours - Area under the curve
Secondary	Left Ventricular Outflow Tract Velocity Time Integral (cm)	Echocardiography	3 hours - Area under the curve
Secondary	Left Ventricular Filling Pressure (mmHg)	Right Heart Catherization	3 hours - Area under the curve