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

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?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05651529
• Other study ID #: 2023-4720
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 16, 2022
• Est. completion date: December 16, 2024

Study information

• Verified date: December 2022
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.
• 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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Université de Sherbrooke	Nestlé Health Science Spain

Country where clinical trial is conducted

Canada, 

Outcome

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