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
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