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Hemodynamic Effects of Chronic Ketosis. (KETO-CHF)

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Ketone monoester (3-OHB)
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)

Isocaloric placebo

Arm Description

Outcomes

Primary Outcome Measures

Resting cardiac output (L/min)
Measured with right heart catheterization

Secondary Outcome Measures

Resting pulmonary capillary wedge pressure (PCWP)
Measured with right heart catheterization
Peak exercise pulmonary capillary wedge pressure (PCWP)
Measured with right heart catheterization
Peak exercise cardiac output (L/min)
Measured with right heart catheterization
Exercise capacity (METs)
Cardiopulmonary exercise test

Full Information

First Posted
December 3, 2021
Last Updated
May 16, 2023
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT05161650
Brief Title
Hemodynamic Effects of Chronic Ketosis.
Acronym
KETO-CHF
Official Title
Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Chronic Heart Failure: Cardiovascular Effects
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2022 (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. We have shown, using positron emission tomography, that ketone body infusion reduces myocardial glucose uptake and increases myocardial blood flow in healthy subjects. Data from another study conducted by our group show a 40% increase in cardiac output during infusion of 3-OHB in patients with HF and reduced left ventricular ejection fraction (HFrEF). Presently there are no data on the clinical cardiovascular 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 cardiac function and exercise capacity 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
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ketone monoester (3-OHB)
Arm Type
Experimental
Arm Title
Isocaloric placebo
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketone monoester (3-OHB)
Intervention Description
Commercially available ketone supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo drink
Intervention Description
Isocaloric placebo
Primary Outcome Measure Information:
Title
Resting cardiac output (L/min)
Description
Measured with right heart catheterization
Time Frame
14 days of dietary supplement
Secondary Outcome Measure Information:
Title
Resting pulmonary capillary wedge pressure (PCWP)
Description
Measured with right heart catheterization
Time Frame
14 days of dietary supplement
Title
Peak exercise pulmonary capillary wedge pressure (PCWP)
Description
Measured with right heart catheterization
Time Frame
14 days of dietary supplement
Title
Peak exercise cardiac output (L/min)
Description
Measured with right heart catheterization
Time Frame
14 days of dietary supplement
Title
Exercise capacity (METs)
Description
Cardiopulmonary exercise test
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

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Hemodynamic Effects of Chronic Ketosis.

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