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Recruiting NCT07527156

Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure

Phase IV Interventional Acute Heart Failure (AHF) Cardiogenic Shock Heart Failure Ketones

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ketone Monoester (KE).
Who it may be relevant to
Registry conditions: Acute Heart Failure (AHF), Cardiogenic Shock, Heart Failure, Ketones. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Dietary supplement Ketone Monoester (KE)
    Continous infusion of a commercially available ketone monoester via nasogastric tube.

Primary outcome measures

  • Proportion of time within the target concentration range [Time frame: 36 hours]
Secondary outcome measures (2)
  • 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]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Czechia · 1 center
  • Institute for Clinical and Experimental Medicine (IKEM) — Prague

Identifiers

NCT: NCT07527156 · A-26-07

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗