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Weight-Adjusted Dosing of 3-OHB in Patients With Chronic Heart Failure

Weight-Adjusted Dosing of 3-OHB in Patients With Chronic Heart Failure

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04594265
Acronym
KINETICS2
Enrollment
8
Registered
2020-10-20
Start date
2020-10-01
Completion date
2022-09-30
Last updated
2022-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Ketosis

Keywords

Hemodynamics

Brief summary

We aim to investigate the hemodynamic effects of weight-adjusted dosing of ketone monoester en patients with chronic heart failure.

Interventions

DIETARY_SUPPLEMENTKetoneAid KE4 Pro Monoester

A dietary supplement containing ketone monoester.

DIETARY_SUPPLEMENTScience in Sport Go Enegy

Dosis isocaloric to the KetoneAid Arm

Sponsors

University of Aarhus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

Patients are studied in a randomized single-blind cross-over design.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Chronic HF: NYHA class II-III, left ventricular ejection fraction (LVEF) \<40%

Exclusion criteria

Diabetes or HbA1c \>48 mmol/mol, significant cardiac valve disease, severe stable angina pectoris, severe comorbidity as judged by the investigator, inability to give informed consent

Design outcomes

Primary

MeasureTime frameDescription
Cardiac Output (L/min)3 hours - Area under the curveChange in Cardiac output measured by Swann-Ganz Catherization during study period,

Secondary

MeasureTime frameDescription
Left Ventricular Ejection Fraction3 hours - Area under the curveChange in LVEF measured by echocardiography during study periode
Blood Ketones3 hoursChange in blood Ketones measured by venous blood samples
Blood pH3 hoursChange in venous blood pH during the study period

Countries

Denmark

Contacts

Primary ContactKristian H Christensen, MD
krstchri@rm.dk+4578452029
Backup ContactHenrik S Wiggers, DMsci

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026