Prolonged nasogastric ketone infusion for decompensated heart failure
Official title: Feasibility and Safety of Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure
Run by Institute for Clinical and Experimental Medicine · NCT07527156 · Data updated 2026-11-12
This will test whether a continuous nasogastric infusion of a ketone (D‑beta‑hydroxybutyrate) can safely reach target blood levels in adults with severely reduced ejection fraction admitted for acute decompensated heart failure or cardiogenic shock.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 12 (estimated) |
| Sponsor | Institute for Clinical and Experimental Medicine Government |
| Locations | 1 site (Prague, Prague) |
| Status | Recruiting |
| Started | April 4, 2026 |
| Main results expected | March 31, 2027 |
| Study ends | March 31, 2027 |
| Registry record updated | April 14, 2026 |
| Trial ID | NCT07527156 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with LVEF <35% admitted to the ICU for acute decompensated heart failure with low cardiac output syndrome or cardiogenic shock who can tolerate nasogastric tube placement and do not have severe liver failure, severe acidosis, gastric paralysis/ileus, repeated vomiting, or severe hypokalemia.
✕Probably not a fit
Patients with severe liver failure, severe acidosis, inability to have an NG tube (for example due to gastric paralysis or repeated vomiting), or severe hypokalemia are excluded and unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with left ventricular ejection fraction under 35% who are admitted to the ICU for acute decompensated heart failure with low cardiac output syndrome or cardiogenic shock will receive a continuous nasogastric infusion of a D‑3‑hydroxybutyrate monoester for 36 hours. The infusion rate will be adjusted iteratively to keep arterial beta‑hydroxybutyrate concentrations between 2.0 and 3.5 mmol/L, with point‑of‑care arterial measurements every 1–3 hours. The primary endpoint is the proportion of time spent within the prespecified target concentration range. Secondary safety endpoints include liver function deterioration not explained by hemodynamic decline, occurrence of cardiac arrhythmias, and gastrointestinal tolerance of the infusion; the intervention is administered at a single center in Prague.
Why it matters
Potential benefit: If successful, this could provide a safe method to raise ketone levels and potentially support cardiac energy supply during acute decompensation.
How similar studies have gone: Small clinical and early‑phase studies have shown that exogenous ketones can alter cardiac metabolism, but prolonged nasogastric infusion in critically ill decompensated heart failure patients is largely novel and untested at scale.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * LVEF \<35% * Acute heart failure with low cardiac output syndrome or cardiogenic shock Exclusion Criteria: * Severe liver failure * Severe acidosis * Inability to insert nasogastric tube * Gastric paralysis / ileus * Repeated vomiting * Severe hypokalemia
Where it's running
-
Institute for Clinical and Experimental Medicine (IKEM)
Prague, Prague, Czechia Recruiting
Study contacts
- Study coordinator: Marek Sramko, MD, PhD
- Email: marek.sramko@ikem.cz
- Phone: +420776246127
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.