Heart FailureNCT04379934
Functional and Metabolic Effects of Ketone Bodies on Human Atrial Tissue in Patients With and Without Heart Failure
A study testing 3-hydroxybuturate in people with Heart Failure and Ischemia Reperfusion Injury, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure, Ischemia Reperfusion Injury, Mitochondrial Pathology
- What is being tested?
- 3-hydroxybuturate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2020to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- EF < / > 45%, hospitalized for elective CABG or heart valve surgery
Who cannot join
- Myocardial infarction within 4 weeks, atrial fibrillation, medically treated thyroid disease, oral treatment with opioids.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University Hospital
Aarhus, 8200
Jacob Seefeldt, M.B., +45 4117633, jacob.seefeldt@clin.au.dk
Bent Roni Nielsen, M.D., Ph.D., +45 51219363, bent.nils@midt.rm.dk
About this study
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.
Read the detailed 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.
- Being tested
- 3-hydroxybuturate
- Medical subject headings
- Heart Failure, Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-hydroxybuturateDietary supplement
3-hydroxybuturate will be administered directly as a modified Krebs Henseleit buffer in a super perfused atrial strips model
| Study group | Role | What they receive |
|---|---|---|
| Heart failure | Other | Ejection fraction < 45% Receives: Dietary Supplement: 3-hydroxybuturate |
| Non-heart failure | Other | Ejection fraction > 45% Receives: Dietary Supplement: 3-hydroxybuturate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contractile force recovery
Atrial strips model, contractile force (nm*mm^-1) during stabilization, ischemia and reperfusion
Measured: Outcome will be assessed within a year when the inclusion of patients is complete
Secondary outcomes (2)
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.
Measured: Outcome will be assessed within a year when the inclusion of patients is complete
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
Measured: Outcome will be assessed within a year when the inclusion of patients is complete
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start1 Jun 2020 (estimated)
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Hans Erik Bøtker, M.D., Prof., Study director, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04379934
- Sponsor's protocol ID
- KetoCard01
- Status last verified
- Apr 2020
- First submitted
- 30 Apr 2020
- Last updated
- 8 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30884964
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional and Metabolic Effects of Ketone Bodies on Human Atrial Tissue in Patients With and Without Heart Failure
- ClinicalTrials.gov ID
- NCT04379934
- Acronym / sponsor ID
- KetoCard01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 8 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart failure | Other | Dietary Supplement: 3-hydroxybuturateEjection fraction < 45% |
| Non-heart failure | Other | Dietary Supplement: 3-hydroxybuturateEjection fraction > 45% |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- EF < / > 45%, hospitalized for elective CABG or heart valve surgery
Key exclusion criteria (1 listed)
- Myocardial infarction within 4 weeks, atrial fibrillation, medically treated thyroid disease, oral treatment with opioids.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3-hydroxybuturate3-hydroxybuturate will be administered directly as a modified Krebs Henseleit buffer in a super perfused atrial strips model | Dietary supplement | Heart failure, Non-heart failure |
Primary outcome
Contractile force recovery
Time frame: Outcome will be assessed within a year when the inclusion of patients is complete
Atrial strips model, contractile force (nm*mm^-1) during stabilization, ischemia and reperfusion
2 secondary outcomes
Mitochondrial respiratory capacity
Time frame: Outcome will be assessed within a year when the inclusion of patients is complete
Mitochondrial Reactive Oxygen Species production
Time frame: Outcome will be assessed within a year when the inclusion of patients is complete
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2020.
- Background: PubMed 30884964Nielsen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Erik Bøtker, M.D., Prof. study director
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-hydroxybuturate in people with Heart Failure and Ischemia Reperfusion Injury, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacob Seefeldt, B.M (+45 41178633, jacob.seefeldt@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contractile force recovery (time frame: Outcome will be assessed within a year when the inclusion of patients is complete). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04379934, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2020.