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Acute Oral Ketones or Carbohydrate Supplement Modify Heart Function in Heart Failure?

Primary Purpose

Heart Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
exogenous ketone salt supplement
exogenous carbohydrate supplement
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Heart Failure focused on measuring Ketones, Heart

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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

Sites / Locations

  • Centre Hospitalier Universitaire de Sherbrooke, departement de cardiologie
  • Centre Hospitalier Universitaire de Sherbrooke, departement de médecine

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Right ventricle ejection fraction by cardiac MRI after intake supplement in heart failure patients.
Measure by Cardiac MR in pourcentage between diastolic and systolic volume in millimeter
Ventricle volume by cardiac MRI after intake supplement in heart failure patients.
Measure by Cardiac MR in millimeter
Cardiac output by cardiac MRI after intake supplement in heart failure patients.
Measure by Cardiac MR in liter per minute
Effects of supplement on serum biomarkers
Concentration of lactate (mmol/L)
Effects of supplement on serum biomarkers
Concentration sodium (mEq/L)
Effects of supplement on serum biomarkers
Concentration of N-terminal pro-B-type natriuretic peptide (NT-proBNP) (pg/ml)
Effects of supplement on serum biomarkers
Concentration of Beta-Hydroxybutyrate (mmol/L)
Effects of supplement on serum biomarkers
Concentration of glucose (mmol/L)
Effects of supplement on serum biomarkers
Concentration of insulin (IU)
Effects of supplement on the blood pressure of heart failure patients
Measure the blood pressure in systole and diastole in mm Hg
Effects of supplement on the heart rate of heart failure patients
Measure the heart rate in beat per minute

Full Information

First Posted
November 29, 2022
Last Updated
December 12, 2022
Sponsor
Université de Sherbrooke
Collaborators
Nestlé Health Science Spain
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1. Study Identification

Unique Protocol Identification Number
NCT05651529
Brief Title
Acute Oral Ketones or Carbohydrate Supplement Modify Heart Function in Heart Failure?
Official Title
Does Oral Intake of Beta-hydroxybutyrate Decrease Left Ventricular End-systolic Volume at Cardiac Magnetic Resonance in Patients With Heart Failure Compared to Carbohydrate Placebo?
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 16, 2022 (Anticipated)
Primary Completion Date
December 16, 2023 (Anticipated)
Study Completion Date
December 16, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université de Sherbrooke
Collaborators
Nestlé Health Science Spain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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?
Detailed Description
This study will help to quantify heart and kidney ketone uptake with or without an exogenous ketone salt in heart failure condition. Participants will have 2 different cardiac MRI to perform: Fasting with exogenous ketone salt supplement Fasting with exogenous carbohydrate supplement

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Ketones, Heart

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Crossover Assignment, Each participant will have to do the 2 Acute supplementation interventions
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Triple (Participant, Investigator, Outcomes Assessor) Investigators, participants and outcome assessors will be fully blinded.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
exogenous ketone salt supplement
Other Intervention Name(s)
Post-Prandial with exogenous ketone salt supplement
Intervention Description
Dietary Supplement: Fasting water and with exogenous ketone salt supplement. Participants will have to take 1 doses of supplement 30 minutes before the scan.
Intervention Type
Dietary Supplement
Intervention Name(s)
exogenous carbohydrate supplement
Other Intervention Name(s)
Post-Prandial with exogenous carbohydrate supplement
Intervention Description
Dietary Supplement: Fasting water and with exogenous carbohydrate supplement. Participants will have to take 1 doses of supplement 30 minutes before the scan.
Primary Outcome Measure Information:
Title
Left ventricle ejection fraction by cardiac MRI under acute intake of exogenous ketone salt compared with exogenous carbohydrate placebo in heart failure patients.
Description
Measure by Cardiac MR in pourcentage between diastolic and systolic volume in millimeter
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Right ventricle ejection fraction by cardiac MRI after intake supplement in heart failure patients.
Description
Measure by Cardiac MR in pourcentage between diastolic and systolic volume in millimeter
Time Frame
15 minutes
Title
Ventricle volume by cardiac MRI after intake supplement in heart failure patients.
Description
Measure by Cardiac MR in millimeter
Time Frame
15 minutes
Title
Cardiac output by cardiac MRI after intake supplement in heart failure patients.
Description
Measure by Cardiac MR in liter per minute
Time Frame
15 minutes
Title
Effects of supplement on serum biomarkers
Description
Concentration of lactate (mmol/L)
Time Frame
60 minutes
Title
Effects of supplement on serum biomarkers
Description
Concentration sodium (mEq/L)
Time Frame
60 minutes
Title
Effects of supplement on serum biomarkers
Description
Concentration of N-terminal pro-B-type natriuretic peptide (NT-proBNP) (pg/ml)
Time Frame
60 minutes
Title
Effects of supplement on serum biomarkers
Description
Concentration of Beta-Hydroxybutyrate (mmol/L)
Time Frame
60 minutes
Title
Effects of supplement on serum biomarkers
Description
Concentration of glucose (mmol/L)
Time Frame
60 minutes
Title
Effects of supplement on serum biomarkers
Description
Concentration of insulin (IU)
Time Frame
60 minutes
Title
Effects of supplement on the blood pressure of heart failure patients
Description
Measure the blood pressure in systole and diastole in mm Hg
Time Frame
60 minutes
Title
Effects of supplement on the heart rate of heart failure patients
Description
Measure the heart rate in beat per minute
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Sherbrooke, departement de cardiologie
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Sherbrooke, departement de médecine
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Acute Oral Ketones or Carbohydrate Supplement Modify Heart Function in Heart Failure?

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