Back to resultsWeight-Adjusted Dosing of 3-OHB in Patients With Chronic Heart Failure (KINETICS2)
Primary Purpose
Heart Failure, Ketosis
Status
Recruiting
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
KetoneAid KE4 Pro Monoester
Science in Sport Go Enegy
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Hemodynamics
Eligibility Criteria
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
Sites / Locations
- Aarhus University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
Ketone Monoester
Placebo Treatment
Ketone Monoester in presence of low-dose insulin clamp
Arm Description
Weight-adjusted dose of 3-OHB Monoester (KetoneAID KE4, Virginia, US) 0.5 g/kg (max 50 g)
Maltodextrin-based placebo (Science In Sport, UK) in isocaloric dose to the experimental arm.
Same as experimental arm, but in the presence of a low-dose insulin clamp to suppress free fatty acid metabolism
Outcomes
Primary Outcome Measures
Cardiac Output (L/min)
Change in Cardiac output measured by Swann-Ganz Catherization during study period,
Secondary Outcome Measures
Left Ventricular Ejection Fraction
Change in LVEF measured by echocardiography during study periode
Blood Ketones
Change in blood Ketones measured by venous blood samples
Blood pH
Change in venous blood pH during the study period
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04594265
Brief Title
Weight-Adjusted Dosing of 3-OHB in Patients With Chronic Heart Failure
Acronym
KINETICS2
Official Title
Weight-Adjusted Dosing of 3-OHB in Patients With Chronic Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
We aim to investigate the hemodynamic effects of weight-adjusted dosing of ketone monoester en patients with chronic heart failure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Ketosis
Keywords
Hemodynamics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Model Description
Patients are studied in a randomized single-blind cross-over design.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ketone Monoester
Arm Type
Experimental
Arm Description
Weight-adjusted dose of 3-OHB Monoester (KetoneAID KE4, Virginia, US) 0.5 g/kg (max 50 g)
Arm Title
Placebo Treatment
Arm Type
Placebo Comparator
Arm Description
Maltodextrin-based placebo (Science In Sport, UK) in isocaloric dose to the experimental arm.
Arm Title
Ketone Monoester in presence of low-dose insulin clamp
Arm Type
Active Comparator
Arm Description
Same as experimental arm, but in the presence of a low-dose insulin clamp to suppress free fatty acid metabolism
Intervention Type
Dietary Supplement
Intervention Name(s)
KetoneAid KE4 Pro Monoester
Intervention Description
A dietary supplement containing ketone monoester.
Intervention Type
Dietary Supplement
Intervention Name(s)
Science in Sport Go Enegy
Intervention Description
Dosis isocaloric to the KetoneAid Arm
Primary Outcome Measure Information:
Title
Cardiac Output (L/min)
Description
Change in Cardiac output measured by Swann-Ganz Catherization during study period,
Time Frame
3 hours - Area under the curve
Secondary Outcome Measure Information:
Title
Left Ventricular Ejection Fraction
Description
Change in LVEF measured by echocardiography during study periode
Time Frame
3 hours - Area under the curve
Title
Blood Ketones
Description
Change in blood Ketones measured by venous blood samples
Time Frame
3 hours
Title
Blood pH
Description
Change in venous blood pH during the study period
Time Frame
3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristian H Christensen, MD
Phone
+4578452029
Email
krstchri@rm.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Henrik S Wiggers, DMsci
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristian H Christensen, MD
Email
krstchri@rm.dk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Weight-Adjusted Dosing of 3-OHB in Patients With Chronic Heart Failure
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