NCT04594265

Brief Summary

We aim to investigate the hemodynamic effects of weight-adjusted dosing of ketone monoester en patients with chronic heart failure.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for phase_2 heart-failure

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

July 18, 2022

Status Verified

July 1, 2022

Enrollment Period

2 years

First QC Date

October 13, 2020

Last Update Submit

July 14, 2022

Conditions

Heart FailureKetosis

Keywords

Hemodynamics

Outcome Measures

Primary Outcomes (1)

  • Cardiac Output (L/min)

    Change in Cardiac output measured by Swann-Ganz Catherization during study period,

    3 hours - Area under the curve

Secondary Outcomes (3)

  • Left Ventricular Ejection Fraction

    3 hours - Area under the curve

  • Blood Ketones

    3 hours

  • Blood pH

    3 hours

Study Arms (3)

Ketone Monoester

EXPERIMENTAL

Weight-adjusted dose of 3-OHB Monoester (KetoneAID KE4, Virginia, US) 0.5 g/kg (max 50 g)

Dietary Supplement: KetoneAid KE4 Pro Monoester

Placebo Treatment

PLACEBO COMPARATOR

Maltodextrin-based placebo (Science In Sport, UK) in isocaloric dose to the experimental arm.

Dietary Supplement: Science in Sport Go Enegy

Ketone Monoester in presence of low-dose insulin clamp

ACTIVE COMPARATOR

Same as experimental arm, but in the presence of a low-dose insulin clamp to suppress free fatty acid metabolism

Dietary Supplement: KetoneAid KE4 Pro Monoester

Interventions

KetoneAid KE4 Pro MonoesterDIETARY_SUPPLEMENT

A dietary supplement containing ketone monoester.

Ketone MonoesterKetone Monoester in presence of low-dose insulin clamp
Science in Sport Go EnegyDIETARY_SUPPLEMENT

Dosis isocaloric to the KetoneAid Arm

Placebo Treatment

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

MeSH Terms

Conditions

Heart FailureKetosis

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesAcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Kristian H Christensen, MD

CONTACT

+4578452029krstchri@rm.dk

Henrik S Wiggers, DMsci

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Patients are studied in a randomized single-blind cross-over design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 13, 2020

First Posted

October 20, 2020

Study Start

October 1, 2020

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

July 18, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)