Hemodynamic Effects of Chronic Ketosis.

NCT05161650 | Completed Phase 2 DMC

• 1 other identifier: KETO-CHF
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Resting cardiac output (L/min)

  Measured with right heart catheterization

  14 days of dietary supplement

Secondary Outcomes (4)

• Resting pulmonary capillary wedge pressure (PCWP)

  14 days of dietary supplement

• Peak exercise pulmonary capillary wedge pressure (PCWP)

  14 days of dietary supplement

• Peak exercise cardiac output (L/min)

  14 days of dietary supplement

• Exercise capacity (METs)

  14 days of dietary supplement

Study Arms (2)

Ketone monoester (3-OHB)

EXPERIMENTAL

Dietary Supplement: Ketone monoester (3-OHB)

Isocaloric placebo

EXPERIMENTAL

Dietary Supplement: Placebo drink

Interventions

Ketone monoester (3-OHB) DIETARY_SUPPLEMENT

Commercially available ketone supplement

Ketone monoester (3-OHB)

Placebo drink DIETARY_SUPPLEMENT

Isocaloric placebo

Isocaloric placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic heart failure with NYHA II-III
• Left ventricular ejection fraction ≤40%
• Negative urine-HCG for women with childbearing potential

You may not qualify if:

• Known diabetes or HbA1c ≥48 mmol/mol
• Significant cardiac valve disease
• Severe stable angina pectoris
• Age \<18 years

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, DK-8200, Denmark

Location

Related Publications (1)

• Berg-Hansen K, Gopalasingam N, Christensen KH, Ladefoged B, Andersen MJ, Poulsen SH, Borlaug BA, Nielsen R, Moller N, Wiggers H. Cardiovascular Effects of Oral Ketone Ester Treatment in Patients With Heart Failure With Reduced Ejection Fraction: A Randomized, Controlled, Double-Blind Trial. Circulation. 2024 May 7;149(19):1474-1489. doi: 10.1161/CIRCULATIONAHA.123.067971. Epub 2024 Mar 27.

  PMID: 38533643 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: December 17, 2021
• Study Start: January 15, 2022
• Primary Completion: May 1, 2023
• Study Completion: November 1, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-11

Locations

DK (1)