Heart Failure Clinical Trial
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?
Verified date | December 2022 |
Source | Université de Sherbrooke |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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?
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | December 16, 2024 |
Est. primary completion date | December 16, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Centre Hospitalier Universitaire de Sherbrooke, departement de cardiologie | Sherbrooke | Quebec |
Canada | Centre Hospitalier Universitaire de Sherbrooke, departement de médecine | Sherbrooke | Quebec |
Lead Sponsor | Collaborator |
---|---|
Université de Sherbrooke | Nestlé Health Science Spain |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | Ventricle volume by cardiac MRI after intake supplement in heart failure patients. | Measure by Cardiac MR in millimeter | 15 minutes | |
Secondary | Cardiac output by cardiac MRI after intake supplement in heart failure patients. | Measure by Cardiac MR in liter per minute | 15 minutes | |
Secondary | Effects of supplement on serum biomarkers | Concentration of lactate (mmol/L) | 60 minutes | |
Secondary | Effects of supplement on serum biomarkers | Concentration sodium (mEq/L) | 60 minutes | |
Secondary | Effects of supplement on serum biomarkers | Concentration of N-terminal pro-B-type natriuretic peptide (NT-proBNP) (pg/ml) | 60 minutes | |
Secondary | Effects of supplement on serum biomarkers | Concentration of Beta-Hydroxybutyrate (mmol/L) | 60 minutes | |
Secondary | Effects of supplement on serum biomarkers | Concentration of glucose (mmol/L) | 60 minutes | |
Secondary | Effects of supplement on serum biomarkers | Concentration of insulin (IU) | 60 minutes | |
Secondary | Effects of supplement on the blood pressure of heart failure patients | Measure the blood pressure in systole and diastole in mm Hg | 60 minutes | |
Secondary | Effects of supplement on the heart rate of heart failure patients | Measure the heart rate in beat per minute | 60 minutes |
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