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

Phase 2

• Conditions: Heart Failure; Ketosis
• Interventions: Dietary Supplement: KetoneAid KE4 Pro Monoester; Dietary Supplement: Science in Sport Go Enegy

• Registration Number: NCT04594265
• Lead Sponsor: University of Aarhus

Brief Summary

We aim to investigate the hemodynamic effects of weight-adjusted dosing of ketone monoester en patients with chronic 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: 2020-10-01
• Study First Submitted: 2020-10-13
• Study First Submitted QC: 2020-10-13
• Study First Posted: 2020-10-20
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-14
• Last Update Posted: 2022-07-18
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Not provided

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ketone Monoester	KetoneAid KE4 Pro Monoester	Weight-adjusted dose of 3-OHB Monoester (KetoneAID KE4, Virginia, US) 0.5 g/kg (max 50 g)
Placebo Treatment	Science in Sport Go Enegy	Maltodextrin-based placebo (Science In Sport, UK) in isocaloric dose to the experimental arm.
Ketone Monoester in presence of low-dose insulin clamp	KetoneAid KE4 Pro Monoester	Same as experimental arm, but in the presence of a low-dose insulin clamp to suppress free fatty acid metabolism

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark