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NCT Number: NCT07527156

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Institute for Clinical and Experimental Medicine (IKEM)

Prague, 14021, Czechia

Location status: Recruiting

Location contact

Marek Sramko, MD, PhD

CONTACT

[email protected]

+420776246127

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketone Monoester (KE)

Dietary Supplement

Continous infusion of a commercially available ketone monoester via nasogastric tube.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Worsening of liver function

    Time frame: During 72 hours within from start of the study intervention

    Increase of ALT, AST or GGT > 2x from baseline

  2. GIT tolerance

    Time frame: During 36 hours of the study

    Occurrence of repeated vomiting or patient-reported gastrointestinal intolerance considered to limit continuation of the infusion.

Study contacts

Contact information is provided by the study sponsor or research team.

Marek Sramko, MD, PhD

CONTACT

[email protected]

+420776246127

Sponsors and collaborators

Lead sponsor

Institute for Clinical and Experimental Medicine

Other Gov

Registry information

Official study title

Feasibility and Safety of Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure

Acronym: KADHEF-2

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 14, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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