search
Back to results

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
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
December 3, 2021
Last Updated
January 11, 2022
Sponsor
University of Aarhus
search

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)

We'll reach out to this number within 24 hrs