NCT05651529

Brief Summary

Does oral intake of exogenous ketone salt improve heart function measured by cardiac MRI in heart failure compared to oral intake of a carbohydrate placebo?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

November 29, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 15, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

December 16, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2025

Completed
Last Updated

January 7, 2026

Status Verified

June 1, 2025

Enrollment Period

3 years

First QC Date

November 29, 2022

Last Update Submit

January 2, 2026

Conditions

Heart Failure

Keywords

KetonesHeart

Outcome Measures

Primary Outcomes (1)

  • Left ventricle ejection fraction by cardiac MRI under acute intake of exogenous ketone salt compared with exogenous carbohydrate placebo in heart failure patients.

    Measure by Cardiac MR in pourcentage between diastolic and systolic volume in millimeter

    15 minutes

Secondary Outcomes (11)

  • Right ventricle ejection fraction by cardiac MRI after intake supplement in heart failure patients.

    15 minutes

  • Ventricle volume by cardiac MRI after intake supplement in heart failure patients.

    15 minutes

  • Cardiac output by cardiac MRI after intake supplement in heart failure patients.

    15 minutes

  • Effects of supplement on serum biomarkers

    60 minutes

  • Effects of supplement on serum biomarkers

    60 minutes

  • +6 more secondary outcomes

Study Arms (2)

Ketone

ACTIVE COMPARATOR
Dietary Supplement: exogenous ketone salt supplement

Placebo

PLACEBO COMPARATOR
Dietary Supplement: exogenous carbohydrate supplement

Interventions

exogenous ketone salt supplementDIETARY_SUPPLEMENT

Dietary Supplement: Fasting water and with exogenous ketone salt supplement. Participants will have to take 1 doses of supplement 30 minutes before the scan.

Also known as: Post-Prandial with exogenous ketone salt supplement
Ketone
exogenous carbohydrate supplementDIETARY_SUPPLEMENT

Dietary Supplement: Fasting water and with exogenous carbohydrate supplement. Participants will have to take 1 doses of supplement 30 minutes before the scan.

Also known as: Post-Prandial with exogenous carbohydrate supplement
Placebo

Eligibility Criteria

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

You may qualify if:

  • Patients with heart failure with left ventricle ejection fraction of 40%
  • Heart failure of ischemic or dilated etiology
  • Ambulatory patient with a NYHA functional class of II-III;
  • Stable symptoms and no change in medical therapy in the last month.

You may not qualify if:

  • Diabetes
  • Patients treated with any SGLT2i;
  • Chronic kidney disease
  • Acute coronary syndrome in the last 3 months;
  • Use of parenteral inotropic agents;
  • Persistent or permanent atrial fibrillation or atrial flutter;
  • Presence of pacemaker or defibrillator;
  • Medical condition that causes malabsorption of the test material;
  • Under ketogenic diet, or using exogenous ketone supplements
  • Use of nicotinamide adenine dinucleotide (NAD) precursor supplements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier Universitaire de Sherbrooke, departement de cardiologie

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke, departement de médecine

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Heart FailureKetosis

Interventions

Postprandial Period

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesAcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Digestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Triple (Participant, Investigator, Outcomes Assessor) Investigators, participants and outcome assessors will be fully blinded.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Crossover Assignment, Each participant will have to do the 2 Acute supplementation interventions
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2022

First Posted

December 15, 2022

Study Start

December 16, 2022

Primary Completion

December 16, 2025

Study Completion

December 16, 2025

Last Updated

January 7, 2026

Record last verified: 2025-06

Locations

CA(2)