Heart FailurePhase 2KINETICS2NCT04594265
Weight-Adjusted Dosing of 3-OHB in Patients With Chronic Heart Failure
A Phase 2 study testing KetoneAid KE4 Pro Monoester and Science in Sport Go Enegy in people with Heart Failure and Ketosis, run by University of Aarhus at 1 site in Denmark.
Trial summary
We aim to investigate the hemodynamic effects of weight-adjusted dosing of ketone monoester en patients with chronic heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Ketosis
- What is being tested?
- KetoneAid KE4 Pro Monoester and Science in Sport Go Enegy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2020to 30 Sep 2022
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
Henrik S Wiggers, DMsci contact
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, 8200
Kristian H Christensen, MD, krstchri@rm.dk
About this study
We aim to investigate the hemodynamic effects of weight-adjusted dosing of ketone monoester en patients with chronic heart failure.
- Conditions
- Heart Failure, Ketosis
- Being tested
- KetoneAid KE4 Pro Monoester, Science in Sport Go Enegy
- Keywords
- Hemodynamics
- Medical subject headings
- Heart Failure, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetoneAid KE4 Pro MonoesterDietary supplement
A dietary supplement containing ketone monoester.
Science in Sport Go EnegyDietary supplement
Dosis isocaloric to the KetoneAid Arm
| Study group | Role | What they receive |
|---|---|---|
| Ketone Monoester | Experimental | Weight-adjusted dose of 3-OHB Monoester (KetoneAID KE4, Virginia, US) 0.5 g/kg (max 50 g) Receives: Dietary Supplement: KetoneAid KE4 Pro Monoester |
| Placebo Treatment | Placebo comparator | Maltodextrin-based placebo (Science In Sport, UK) in isocaloric dose to the experimental arm. Receives: Dietary Supplement: Science in Sport Go Enegy |
| Ketone Monoester in presence of low-dose insulin clamp | Active comparator | Same as experimental arm, but in the presence of a low-dose insulin clamp to suppress free fatty acid metabolism Receives: Dietary Supplement: KetoneAid KE4 Pro Monoester |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Output (L/min)
Change in Cardiac output measured by Swann-Ganz Catherization during study period,
Measured: 3 hours - Area under the curve
Secondary outcomes (3)
Left Ventricular Ejection Fraction
Change in LVEF measured by echocardiography during study periode
Measured: 3 hours - Area under the curve
Blood Ketones
Change in blood Ketones measured by venous blood samples
Measured: 3 hours
Blood pH
Change in venous blood pH during the study period
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start1 Oct 2020
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Patients are studied in a randomized single-blind cross-over design.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristian Hylleberg Christensen, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04594265
- Sponsor's protocol ID
- KETO-KINETICS 2 1-10-72-23-20
- Acronym
- KINETICS2
- Status last verified
- Jul 2022
- First submitted
- 13 Oct 2020
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight-Adjusted Dosing of 3-OHB in Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT04594265
- Acronym / sponsor ID
- KINETICS2 / KETO-KINETICS 2 1-10-72-23-20
- Conditions
- Heart Failure, Ketosis
- Keywords
- Hemodynamics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 20 Oct 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.
We aim to investigate the hemodynamic effects of weight-adjusted dosing of ketone monoester en patients with chronic heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Patients are studied in a randomized single-blind cross-over design.
| Arm | Type | Receives |
|---|---|---|
| Ketone Monoester | Experimental | Dietary Supplement: KetoneAid KE4 Pro MonoesterWeight-adjusted dose of 3-OHB Monoester (KetoneAID KE4, Virginia, US) 0.5 g/kg (max 50 g) |
| Placebo Treatment | Placebo comparator | Dietary Supplement: Science in Sport Go EnegyMaltodextrin-based placebo (Science In Sport, UK) in isocaloric dose to the experimental arm. |
| Ketone Monoester in presence of low-dose insulin clamp | Active comparator | Dietary Supplement: KetoneAid KE4 Pro MonoesterSame as experimental arm, but in the presence of a low-dose insulin clamp to suppress free fatty acid metabolism |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| KetoneAid KE4 Pro MonoesterA dietary supplement containing ketone monoester. | Dietary supplement | Ketone Monoester, Ketone Monoester in presence of low-dose insulin clamp |
| Science in Sport Go EnegyDosis isocaloric to the KetoneAid Arm | Dietary supplement | Placebo Treatment |
Primary outcome
Cardiac Output (L/min)
Time frame: 3 hours - Area under the curve
Change in Cardiac output measured by Swann-Ganz Catherization during study period,
3 secondary outcomes
Left Ventricular Ejection Fraction
Time frame: 3 hours - Area under the curve
Blood Ketones
Time frame: 3 hours
Blood pH
Time frame: 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- 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.
Henrik S Wiggers, DMsci contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KetoneAid KE4 Pro Monoester and Science in Sport Go Enegy in people with Heart Failure and Ketosis, 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?
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 18 Jul 2022. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Kristian H Christensen, MD (+4578452029, krstchri@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Output (L/min) (time frame: 3 hours - Area under the curve). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2022; AzTrials last refreshed its copy on 7 Nov 2026.