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

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?

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Dietary supplement: exogenous ketone salt supplement; Dietary supplement: exogenous carbohydrate supplement

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:

1. Fasting with exogenous ketone salt supplement
2. Fasting with exogenous carbohydrate supplement

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Centre Hospitalier Universitaire de Sherbrooke, departement de cardiologie
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Centre Hospitalier Universitaire de Sherbrooke, departement de médecine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	15 minutes
Ventricle volume by cardiac MRI after intake supplement in heart failure patients.	Measure by Cardiac MR in millimeter	15 minutes
Cardiac output by cardiac MRI after intake supplement in heart failure patients.	Measure by Cardiac MR in liter per minute	15 minutes
Effects of supplement on serum biomarkers	Concentration of lactate (mmol/L)	60 minutes
Effects of supplement on serum biomarkers	Concentration sodium (mEq/L)	60 minutes
Effects of supplement on serum biomarkers	Concentration of N-terminal pro-B-type natriuretic peptide (NT-proBNP) (pg/ml)	60 minutes
Effects of supplement on serum biomarkers	Concentration of Beta-Hydroxybutyrate (mmol/L)	60 minutes
Effects of supplement on serum biomarkers	Concentration of glucose (mmol/L)	60 minutes
Effects of supplement on serum biomarkers	Concentration of insulin (IU)	60 minutes
Effects of supplement on the blood pressure of heart failure patients	Measure the blood pressure in systole and diastole in mm Hg	60 minutes
Effects of supplement on the heart rate of heart failure patients	Measure the heart rate in beat per minute	60 minutes

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Collaborators: Nestlé Health Science Spain

Study record dates

Study Major Dates

• Study Start (Anticipated): December 16, 2022
• Primary Completion (Anticipated): December 16, 2023
• Study Completion (Anticipated): December 16, 2024

Study Registration Dates

• First Submitted: November 29, 2022
• First Submitted That Met QC Criteria: December 12, 2022
• First Posted (Estimate): December 15, 2022

Study Record Updates

• Last Update Posted (Estimate): December 15, 2022
• Last Update Submitted That Met QC Criteria: December 12, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Heart; Ketones
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2023-4720

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No