NCT07527156

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
10mo left

Started Apr 2026

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress20%
Apr 2026Mar 2027

Study Start

First participant enrolled

April 4, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 14, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

April 7, 2026

Last Update Submit

April 7, 2026

Conditions

Acute Heart Failure (AHF)Cardiogenic ShockHeart FailureKetonesKetone Body Metabolism

Keywords

acute heart failureketonesketone body

Outcome Measures

Primary Outcomes (1)

  • 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.

    36 hours

Secondary Outcomes (2)

  • Worsening of liver function

    During 72 hours within from start of the study intervention

  • GIT tolerance

    During 36 hours of the study

Study Arms (1)

Treated patients

ACTIVE COMPARATOR

Observational cohort of patients receiving 3-OHB

Dietary Supplement: Ketone Monoester (KE)

Interventions

Ketone Monoester (KE)DIETARY_SUPPLEMENT

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

Treated patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • LVEF \<35%
  • Acute heart failure with low cardiac output syndrome or cardiogenic shock

You may not qualify if:

  • Severe liver failure
  • Severe acidosis
  • Inability to insert nasogastric tube
  • Gastric paralysis / ileus
  • Repeated vomiting
  • Severe hypokalemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Clinical and Experimental Medicine (IKEM)

Prague, Prague, 14021, Czechia

RECRUITING

MeSH Terms

Conditions

Shock, CardiogenicHeart FailureKetosis

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShockAcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Marek Sramko, MD, PhD

CONTACT

+420776246127marek.sramko@ikem.cz

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Acute Cardiology

Study Record Dates

First Submitted

April 7, 2026

First Posted

April 14, 2026

Study Start

April 4, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)