Weight-Adjusted Dosing of 3-OHB in Patients With Chronic Heart Failure (KINETICS2)

We aim to investigate the hemodynamic effects of weight-adjusted dosing of ketone monoester en patients with chronic heart failure.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Ketosis
• Intervention / Treatment: Dietary supplement: KetoneAid KE4 Pro Monoester; Dietary supplement: Science in Sport Go Enegy

• Study Type: Interventional
• Enrollment (Anticipated): 8
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Kristian H Christensen, MD; Phone Number: +4578452029; Email: krstchri@rm.dk

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Recruiting
    • Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria: Chronic HF: NYHA class II-III, left ventricular ejection fraction (LVEF) <40%

Exclusion Criteria: Diabetes or HbA1c >48 mmol/mol, significant cardiac valve disease, severe stable angina pectoris, severe comorbidity as judged by the investigator, inability to give informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ketone Monoester; Weight-adjusted dose of 3-OHB Monoester (KetoneAID KE4, Virginia, US) 0.5 g/kg (max 50 g)	Dietary supplement: KetoneAid KE4 Pro Monoester; A dietary supplement containing ketone monoester.
Placebo Comparator: Placebo Treatment; Maltodextrin-based placebo (Science In Sport, UK) in isocaloric dose to the experimental arm.	Dietary supplement: Science in Sport Go Enegy; Dosis isocaloric to the KetoneAid Arm
Active Comparator: Ketone Monoester in presence of low-dose insulin clamp; Same as experimental arm, but in the presence of a low-dose insulin clamp to suppress free fatty acid metabolism	Dietary supplement: KetoneAid KE4 Pro Monoester; A dietary supplement containing ketone monoester.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac Output (L/min)	Change in Cardiac output measured by Swann-Ganz Catherization during study period,	3 hours - Area under the curve

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left Ventricular Ejection Fraction	Change in LVEF measured by echocardiography during study periode	3 hours - Area under the curve
Blood Ketones	Change in blood Ketones measured by venous blood samples	3 hours
Blood pH	Change in venous blood pH during the study period	3 hours

Collaborators and Investigators

• Sponsor: University of Aarhus

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: October 13, 2020
• First Submitted That Met QC Criteria: October 13, 2020
• First Posted (Actual): October 20, 2020

Study Record Updates

• Last Update Posted (Actual): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 14, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Hemodynamics
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: KETO-KINETICS 2 1-10-72-23-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No