Acute Heart Failure (AHF)Phase 4KADHEF-2NCT07527156
Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure
A Phase 4 study testing Ketone Monoester (KE) in people with Acute Heart Failure (AHF) and Cardiogenic Shock, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
Trial summary
This study will evaluate the feasibility and safety of achieving therapeutic concentrations of beta-hydroxybutyrate using continuous infusion of D-beta-hydroxybutyrate monoester administered via a nasogastric tube in patients with acutely decompensated heart failure with reduced left ventricular ejection fraction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure (AHF), Cardiogenic Shock, Heart Failure
- What is being tested?
- Ketone Monoester (KE)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCzechia
- Study dates
- 4 Apr 2026to 31 Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- LVEF <35%
- Acute heart failure with low cardiac output syndrome or cardiogenic shock
Who cannot join
- Severe liver failure
- Severe acidosis
- Inability to insert nasogastric tube
- Gastric paralysis / ileus
- Repeated vomiting
- Severe hypokalemia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Institute for Clinical and Experimental Medicine (IKEM)
Prague, Prague, 14021
Marek Sramko, MD, PhD, +420776246127, marek.sramko@ikem.cz
About this study
Official title: Feasibility and Safety of Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure
This study will evaluate the feasibility and safety of achieving therapeutic concentrations of beta-hydroxybutyrate using continuous infusion of D-beta-hydroxybutyrate monoester administered via a nasogastric tube in patients with acutely decompensated heart failure with reduced left ventricular ejection fraction.
Read the detailed description
Adult patients with left ventricular ejection fraction (LVEF) <35% admitted to the intensive care unit for acutely decompensated heart failure with low cardiac output syndrome or cardiogenic shock will receive a continuous infusion of D-3-hydroxybutyrate (3-OHB) monoester via a nasogastric tube for 36 hours. The infusion rate will be iteratively adjusted to achieve an arterial blood concentration of 3-OHB of 2-3.5 mmol/L. Arterial blood concentrations of 3-OHB will be measured every 1-3 hours using point-of-care testing. The primary endpoint will be the proportion of time within the target concentration range. Secondary safety endpoints will include worsening of liver function not attributable to hemodynamic deterioration, occurrence of cardiac arrhythmias, and gastrointestinal tolerance of the infusion.
- Conditions
- Acute Heart Failure (AHF), Cardiogenic Shock, Heart Failure, Ketones, Ketone Body Metabolism
- Being tested
- Ketone Monoester (KE)
- Keywords
- acute heart failure, ketones, ketone body
- Medical subject headings
- Shock, Cardiogenic, Heart Failure, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone Monoester (KE)Dietary supplement
Continous infusion of a commercially available ketone monoester via nasogastric tube.
| Study group | Role | What they receive |
|---|---|---|
| Treated patients | Active comparator | Observational cohort of patients receiving 3-OHB Receives: Dietary Supplement: Ketone Monoester (KE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of time within the target concentration range
Relative time of arterial blood concentration of 3-OHB being in the range of 2 - 3.5 mmol/L.
Measured: 36 hours
Secondary outcomes (2)
Worsening of liver function
Increase of ALT, AST or GGT > 2x from baseline
Measured: During 72 hours within from start of the study intervention
GIT tolerance
Occurrence of repeated vomiting or patient-reported gastrointestinal intolerance considered to limit continuation of the infusion.
Measured: During 36 hours of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start4 Apr 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart Failure (AHF)Studies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute for Clinical and Experimental Medicine
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marek Sramko, MD, PhD, Institute for Clinical and Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527156
- Sponsor's protocol ID
- A-26-07
- Acronym
- KADHEF-2
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT07527156
- Acronym / sponsor ID
- KADHEF-2 / A-26-07
- Conditions
- Acute Heart Failure (AHF), Cardiogenic Shock, Heart Failure, Ketones, Ketone Body Metabolism
- Keywords
- acute heart failure, ketones, ketone body
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Institute for Clinical and Experimental MedicineOther government
- Study start
- 4 Apr 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 14 Apr 2026 (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 study will evaluate the feasibility and safety of achieving therapeutic concentrations of beta-hydroxybutyrate using continuous infusion of D-beta-hydroxybutyrate monoester administered via a nasogastric tube in patients with acutely decompensated heart failure with reduced left ventricular ejection fraction.
Detailed description
Adult patients with left ventricular ejection fraction (LVEF) <35% admitted to the intensive care unit for acutely decompensated heart failure with low cardiac output syndrome or cardiogenic shock will receive a continuous infusion of D-3-hydroxybutyrate (3-OHB) monoester via a nasogastric tube for 36 hours. The infusion rate will be iteratively adjusted to achieve an arterial blood concentration of 3-OHB of 2-3.5 mmol/L. Arterial blood concentrations of 3-OHB will be measured every 1-3 hours using point-of-care testing. The primary endpoint will be the proportion of time within the target concentration range. Secondary safety endpoints will include worsening of liver function not attributable to hemodynamic deterioration, occurrence of cardiac arrhythmias, and gastrointestinal tolerance of the infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated patients | Active comparator | Dietary Supplement: Ketone Monoester (KE)Observational cohort of patients receiving 3-OHB |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- LVEF <35%
- Acute heart failure with low cardiac output syndrome or cardiogenic shock
Key exclusion criteria (6 listed)
- Severe liver failure
- Severe acidosis
- Inability to insert nasogastric tube
- Gastric paralysis / ileus
- Repeated vomiting
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 |
|---|---|---|
| Ketone Monoester (KE)Continous infusion of a commercially available ketone monoester via nasogastric tube. | Dietary supplement | Treated patients |
Primary outcome
Proportion of time within the target concentration range
Time frame: 36 hours
Relative time of arterial blood concentration of 3-OHB being in the range of 2 - 3.5 mmol/L.
2 secondary outcomes
Worsening of liver function
Time frame: During 72 hours within from start of the study intervention
GIT tolerance
Time frame: During 36 hours of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketone Monoester (KE) in people with Acute Heart Failure (AHF) and Cardiogenic Shock, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 14 Apr 2026. 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 Czechia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marek Sramko, MD, PhD (+420776246127, marek.sramko@ikem.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of time within the target concentration range (time frame: 36 hours). 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 14 Apr 2026.