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

Study Overview
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Brief Summary
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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
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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

Official Title
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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?

Conditions
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Heart Failure

Intervention / Treatment
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* Dietary Supplement: exogenous ketone salt supplement
* Dietary Supplement: exogenous carbohydrate supplement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Crossover Assignment, Each participant will have to do the 2 Acute supplementation interventions
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ketones, Heart