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Ketone Monoester
Ketone Monoester for Heart Failure (KINETICS2 Trial)
Phase 2
Waitlist Available
Research Sponsored by University of Aarhus
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Inclusion criteria: Chronic HF: NYHA class II-III, left ventricular ejection fraction (LVEF) \<40%
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 hours
Summary
We aim to investigate the hemodynamic effects of weight-adjusted dosing of ketone monoester en patients with chronic heart failure.
Eligible Conditions
- Heart Failure
- Ketosis
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cardiac Output (L/min)
Secondary study objectives
Blood Ketones
Blood pH
Left Ventricular Ejection Fraction
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Ketone MonoesterExperimental Treatment1 Intervention
Weight-adjusted dose of 3-OHB Monoester (KetoneAID KE4, Virginia, US) 0.5 g/kg (max 50 g)
Group II: Ketone Monoester in presence of low-dose insulin clampActive Control1 Intervention
Same as experimental arm, but in the presence of a low-dose insulin clamp to suppress free fatty acid metabolism
Group III: Placebo TreatmentPlacebo Group1 Intervention
Maltodextrin-based placebo (Science In Sport, UK) in isocaloric dose to the experimental arm.
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Who is running the clinical trial?
University of AarhusLead Sponsor
1,413 Previous Clinical Trials
14,461,101 Total Patients Enrolled
32 Trials studying Heart Failure
5,942,653 Patients Enrolled for Heart Failure
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