Functional and Metabolic Effects of Ketone Bodies on Human Atrial Tissue in Patients With and Without Heart Failure
1 other identifier
interventional
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable heart-failure
Started Jun 2020
Typical duration for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2020
CompletedFirst Posted
Study publicly available on registry
May 8, 2020
CompletedStudy Start
First participant enrolled
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2024
CompletedMay 8, 2020
April 1, 2020
3.7 years
April 30, 2020
May 4, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Mitochondrial respiratory capacity
Outcome will be assessed within a year when the inclusion of patients is complete
Mitochondrial Reactive Oxygen Species production
Outcome will be assessed within a year when the inclusion of patients is complete
Study Arms (2)
Heart failure
OTHEREjection fraction \< 45%
Non-heart failure
OTHEREjection fraction \> 45%
Interventions
3-hydroxybuturate will be administered directly as a modified Krebs Henseleit buffer in a super perfused atrial strips model
Eligibility Criteria
You may qualify if:
- EF \< / \> 45%, hospitalized for elective CABG or heart valve surgery
You may not qualify if:
- Myocardial infarction within 4 weeks, atrial fibrillation, medically treated thyroid disease, oral treatment with opioids.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Aarhus University Hospitalcollaborator
Study Sites (1)
Aarhus University Hospital
Aarhus, 8200, Denmark
Related Publications (1)
Nielsen R, Moller N, Gormsen LC, Tolbod LP, Hansson NH, Sorensen J, Harms HJ, Frokiaer J, Eiskjaer H, Jespersen NR, Mellemkjaer S, Lassen TR, Pryds K, Botker 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.
PMID: 30884964BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hans Erik Bøtker, M.D., Prof.
Aarhus University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2020
First Posted
May 8, 2020
Study Start
June 1, 2020
Primary Completion
January 31, 2024
Study Completion
January 31, 2024
Last Updated
May 8, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share