Prolonged nasogastric ketone infusion for decompensated heart failure
Feasibility and Safety of Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure
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 |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institute for Clinical and Experimental Medicine Government |
| Locations | 1 site (Prague, Prague) |
| Trial ID | NCT07527156 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Prague, Prague
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.