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Clinical Trials/NCT05161650
NCT05161650
Completed
Phase 2

Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Chronic Heart Failure: Cardiovascular Effects

University of Aarhus1 site in 1 country26 target enrollmentJanuary 15, 2022
ConditionsHeart Failure

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Heart Failure
Sponsor
University of Aarhus
Enrollment
26
Locations
1
Primary Endpoint
Resting cardiac output (L/min)
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 15, 2022
End Date
November 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kristoffer Berg-Hansen

Principal Investigator

University of Aarhus

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

Outcomes

Primary Outcomes

Resting cardiac output (L/min)

Time Frame: 14 days of dietary supplement

Measured with right heart catheterization

Secondary Outcomes

  • Peak exercise cardiac output (L/min)(14 days of dietary supplement)
  • Resting pulmonary capillary wedge pressure (PCWP)(14 days of dietary supplement)
  • Peak exercise pulmonary capillary wedge pressure (PCWP)(14 days of dietary supplement)
  • Exercise capacity (METs)(14 days of dietary supplement)

Study Sites (1)

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