Metabolic Effects of Chronic Ketosis (KETO-CHF Metabolic)
Primary Purpose
Heart Failure
Status
Recruiting
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Ketone monoester
Placebo drink
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Chronic heart failure with NYHA II-III
- Left ventricular ejection fraction ≤40%
- Negative urine-HCG for women with childbearing potential
Exclusion Criteria:
- Known diabetes or HbA1c ≥48 mmol/mol
- Significant cardiac valve disease
- Severe stable angina pectoris
- Age <18 years
Sites / Locations
- Aarhus University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Ketone monoester (3-OHB)
Placebo Treatment
Arm Description
Outcomes
Primary Outcome Measures
Differences in lipolysis rate
Measured as differences in palmitate flux
Secondary Outcome Measures
Changes in protein metabolism
Measured with a urea tracer
Changes in glucose kinetic
Measured by glucose tracer
Full Information
NCT ID
NCT05161676
First Posted
December 3, 2021
Last Updated
January 11, 2022
Sponsor
University of Aarhus
1. Study Identification
Unique Protocol Identification Number
NCT05161676
Brief Title
Metabolic Effects of Chronic Ketosis (KETO-CHF Metabolic)
Official Title
Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Chronic Heart Failure: Metabolic Effects
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (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
Heart Failure (HF) is a major public health issue because the disease affects 1-2% of the Western population and the lifetime risk of HF is 20%. Despite major improvements in the management and care of patients with HF, the 1-year mortality in patients with HF is 13% and >50% of HF patients are admitted during a 2.5 year period. Furthermore, patients with HF have markedly decreased physical capacity and quality of life. Thus, there is a need for new treatment modalities in this group of patients.
It is well established that patients with heart failure have metabolic disturbances, including disturbed glucose metabolism with increasing insulin resistance, increased lipolysis, and disturbances in skeletal muscle homeostasis.
Presently there are no data on the clinical metabolic effects of long-term oral ketone-supplementation in patients with chronic HF.
In this study we aim to investigate the effect of 14 days modulation of circulating ketone body levels on endogenous protein, glucose, and fatty acid metabolism in patients with HFrEF.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ketone monoester (3-OHB)
Arm Type
Experimental
Arm Title
Placebo Treatment
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketone monoester
Intervention Description
Commercially available ketone supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo drink
Intervention Description
Isocaloric placebo
Primary Outcome Measure Information:
Title
Differences in lipolysis rate
Description
Measured as differences in palmitate flux
Time Frame
14 days of dietary supplement
Secondary Outcome Measure Information:
Title
Changes in protein metabolism
Description
Measured with a urea tracer
Time Frame
14 days of dietary supplement
Title
Changes in glucose kinetic
Description
Measured by glucose tracer
Time Frame
14 days of dietary supplement
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic heart failure with NYHA II-III
Left ventricular ejection fraction ≤40%
Negative urine-HCG for women with childbearing potential
Exclusion Criteria:
Known diabetes or HbA1c ≥48 mmol/mol
Significant cardiac valve disease
Severe stable angina pectoris
Age <18 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristoffer Berg-Hansen, MD
Phone
60540700
Email
krisbe@rm.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Henrik Wiggers, Professor
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
DK-8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristoffer Berg-Hansen, MD
Email
krisbe@rm.dk
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Metabolic Effects of Chronic Ketosis (KETO-CHF Metabolic)
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