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Functional and Metabolic Effects of Ketone Bodies on Human Atrial Tissue in Patients With and Without Heart Failure

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University of Aarhus

Status

Unknown

Conditions

Ischemia Reperfusion Injury
Heart Failure
Mitochondrial Pathology

Treatments

Dietary Supplement: 3-hydroxybuturate

Study type

Interventional

Funder types

Other

Identifiers

NCT04379934
KetoCard01

Details and patient eligibility

About

This proof of concept study aims to evaluate the effects of applying ketone bodies to human atrial tissue biopsies using an atrial strips model and high resolution respirometry.

Full description

Ketone bodies are high energy molecules which are naturally occurring in the body during fasting or stress.

Recently, ketone bodies have been shown to improve cardiac function in patients with heart failure(1) through a mechanism, which has yet to be elaborated.

We wish to evaluate the effects of ketone body administration on cardiac tissue subjected to ischemia reperfusion injury. We will evaluate contractile force of the and the mitochondrial performance. Cardiac atrial tissue will be obtained from patients undergoing coronary artery bypass grafting (CABG) or valve replacement surgery. Patients will be recruited after signing an informed consent and allocated in heart failure / non-heart failure groups based on a clinical evaluation.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • EF < / > 45%, hospitalized for elective CABG or heart valve surgery

Exclusion criteria

  • Myocardial infarction within 4 weeks, atrial fibrillation, medically treated thyroid disease, oral treatment with opioids.

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Heart failure
Other group
Description:
Ejection fraction \< 45%
Treatment:
Dietary Supplement: 3-hydroxybuturate
Non-heart failure
Other group
Description:
Ejection fraction \> 45%
Treatment:
Dietary Supplement: 3-hydroxybuturate

Trial contacts and locations

1

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Central trial contact

Jacob Seefeldt, B.M; Bent Roni Nielsen, M.D., PhD.

Data sourced from clinicaltrials.gov

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