Acute Heart FailurePhase 1KETO-AHF1NCT04442555
Treatment With the Ketone Body 3-hydroxybutyrate in Patients With Acute Heart Failure
A Phase 1 study testing HVMN Ketone Ester and Maltodextrin in people with Acute Heart Failure, run by University of Aarhus at 1 site in Denmark.
Trial summary
Background: Acute heart failure is a potentially life-threatening condition, reaching mortality rates of up to 50% in advanced cases. The investigators have shown that infusion of ketone bodies increase cardiac output by 40% in stabile patients with chronic heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Acute Heart Failure
- What is being tested?
- HVMN Ketone Ester and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2020to 30 Mar 2023
- Phase
- Phase 1
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized with worsening HF or de novo diagnosis of HF
- LVEF < 50%
- Treatment with intravenous loop diuretics during the hospitalization and/or increased dosage of oral diuretics.
Who cannot join
- Cardiogenic shock
- Systolic Blood Pressure <85 mmHg
- Acute myocardial infarction other than type II <5 days prior to randomization *
- Severe uncorrected cardiac valve disease
- Expected or possible need for hemodialysis as judged by the investigator
- Ongoing inotropic treatment
Show all 12Show fewer
- Possible need for advanced heart failure treatment (LVAD, heart transplantation) as judged by the investigator.
- Ongoing, severe infection
- Severe respiratory distress (SAT<90% or RF> 24/min or receiving more than 2 l O2/min or intubated)
- Atrial Fibrillation with heart >120 beats per minute
- Inability to cooperate to or accept oral intake of food, including presence of major gastrointestinal discomfort.
- If suspected or confirmed acute myocardial infarction as cause of acute heart failure, patients can be recruited 5 days after hospitalization in the absence of malignant arrhythmias (e.g. ventricular tachycardia) or clinically significant residual angina pectoris.
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
Background:
Acute heart failure is a potentially life-threatening condition, reaching mortality rates of up to 50% in advanced cases. The investigators have shown that infusion of ketone bodies increase cardiac output by 40% in stabile patients with chronic heart failure. However, there are no data showing the effects of ketone on patients with acute heart failure
Read more
Objectives:
To investigate the effect of ketone supplementation in patients with acute heart failure and cardiogenic shock, using two different types of oral ketone supplements.
Methods:
The investigators will conduct four randomized placebo-controlled studies, to investigate the hemodynamic effect of exogenous ketones in acute heart failure and cardiogenic shock.
Perspectives:
The present study will determine the potential beneficial effects of ketone supplements in patients with acute heart failure.
- Conditions
- Acute Heart Failure
- Being tested
- HVMN Ketone Ester, Maltodextrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HVMN Ketone EsterDietary supplement
Commercially available ketone supplement
MaltodextrinDietary supplement
Commercially available maltodextrin supplement
| Study group | Role | What they receive |
|---|---|---|
| 3-Hydroxybutyrate treatment | Experimental | HVMN Ketone Ester 0,5 g / kg Receives: Dietary Supplement: HVMN Ketone Ester |
| Placebo Treatment | Placebo comparator | Maltodextrin-base isocaloric placebo Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Output (L/min)
Right Heart Catherization
Measured: 3 hours - Area under the curve
Left Ventricular Ejection Fraction
Echocardiography
Measured: 3 hours - Area under the curve
Secondary outcomes (2)
Left Ventricular Outflow Tract Velocity Time Integral (cm)
Echocardiography
Measured: 3 hours - Area under the curve
Left Ventricular Filling Pressure (mmHg)
Right Heart Catherization
Measured: 3 hours - Area under the curve
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start1 Feb 2020
- Primary completion30 Mar 2023 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristian Hylleberg Christensen, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442555
- Sponsor's protocol ID
- KETO-AHF1 1-10-72-59-19
- Acronym
- KETO-AHF1
- Status last verified
- Jul 2022
- First submitted
- 18 Jun 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
- Treatment With the Ketone Body 3-hydroxybutyrate in Patients With Acute Heart Failure
- ClinicalTrials.gov ID
- NCT04442555
- Acronym / sponsor ID
- KETO-AHF1 / KETO-AHF1 1-10-72-59-19
- Conditions
- Acute Heart Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 22 Jun 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.
Background:
Acute heart failure is a potentially life-threatening condition, reaching mortality rates of up to 50% in advanced cases. The investigators have shown that infusion of ketone bodies increase cardiac output by 40% in stabile patients with chronic heart failure. However, there are no data showing the effects of ketone on patients with acute heart failure
Objectives:
To investigate the effect of ketone supplementation in patients with acute heart failure and cardiogenic shock, using two different types of oral ketone supplements.
Methods:
The investigators will conduct four randomized placebo-controlled studies, to investigate the hemodynamic effect of exogenous ketones in acute heart failure and cardiogenic shock.
Perspectives:
The present study will determine the potential beneficial effects of ketone supplements in patients with acute heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3-Hydroxybutyrate treatment | Experimental | Dietary Supplement: HVMN Ketone EsterHVMN Ketone Ester 0,5 g / kg |
| Placebo Treatment | Placebo comparator | Dietary Supplement: MaltodextrinMaltodextrin-base isocaloric placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hospitalized with worsening HF or de novo diagnosis of HF
- LVEF < 50%
- Treatment with intravenous loop diuretics during the hospitalization and/or increased dosage of oral diuretics.
Key exclusion criteria (12 listed)
- Cardiogenic shock
- Systolic Blood Pressure <85 mmHg
- Acute myocardial infarction other than type II <5 days prior to randomization *
- Severe uncorrected cardiac valve disease
- Expected or possible need for hemodialysis as judged by the investigator
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 |
|---|---|---|
| HVMN Ketone EsterCommercially available ketone supplement | Dietary supplement | 3-Hydroxybutyrate treatment |
| MaltodextrinCommercially available maltodextrin supplement | Dietary supplement | Placebo Treatment |
Primary outcome
Cardiac Output (L/min)
Time frame: 3 hours - Area under the curve
Right Heart Catherization
Left Ventricular Ejection Fraction
Time frame: 3 hours - Area under the curve
Echocardiography
2 secondary outcomes
Left Ventricular Outflow Tract Velocity Time Integral (cm)
Time frame: 3 hours - Area under the curve
Left Ventricular Filling Pressure (mmHg)
Time frame: 3 hours - Area under the curve
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
Related trials for Acute Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Not yet recruitingPhase 3
Early Discharge With Subcutaneous Furosemide Versus Standard Care in Acute Heart Failure
Heart Failure, Acute Decompensated Heart Failure
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
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 1 study testing HVMN Ketone Ester and Maltodextrin in people with Acute Heart Failure, 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 3 inclusion and 12 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 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 (26603577, kristianhylleberg@gmail.com), 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). The study lists 2 primary outcomes in all. 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.