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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04379934
Other study ID # KetoCard01
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2020
Est. completion date January 31, 2024

Study information

Verified date April 2020
Source University of Aarhus
Contact Jacob Seefeldt, B.M
Phone +45 41178633
Email jacob.seefeldt@clin.au.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date January 31, 2024
Est. primary completion date January 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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.

Study Design


Intervention

Dietary Supplement:
3-hydroxybuturate
3-hydroxybuturate will be administered directly as a modified Krebs Henseleit buffer in a super perfused atrial strips model

Locations

Country Name City State
Denmark Aarhus University Hospital Aarhus

Sponsors (2)

Lead Sponsor Collaborator
University of Aarhus Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Nielsen R, Møller N, Gormsen LC, Tolbod LP, Hansson NH, Sorensen J, Harms HJ, Frøkiær J, Eiskjaer H, Jespersen NR, Mellemkjaer S, Lassen TR, Pryds K, Bøtker HE, Wiggers H. Cardiovascular Effects of Treatment With the Ketone Body 3-Hydroxybutyrate in Chronic Heart Failure Patients. Circulation. 2019 Apr 30;139(18):2129-2141. doi: 10.1161/CIRCULATIONAHA.118.036459. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Contractile force recovery Atrial strips model, contractile force (nm*mm^-1) during stabilization, ischemia and reperfusion Outcome will be assessed within a year when the inclusion of patients is complete
Secondary Mitochondrial respiratory capacity High Resolution Respirometry, Complex I and Complex I+II respiration (pmol O2 · s-1·mg-1) assessed via a substrate and inhibitor (SUIT) protocol. Outcome will be assessed within a year when the inclusion of patients is complete
Secondary Mitochondrial Reactive Oxygen Species production High Resolution FluoRespirometry, Complex I and Complex I+II linked ROS generation measured with AmplexUltra red and H2O2 interaction fluorescense Outcome will be assessed within a year when the inclusion of patients is complete
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