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

Not Applicable

Not yet recruiting

• Conditions: Heart Failure

• Registration Number: NCT05651529
• Lead Sponsor: Université de Sherbrooke

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:

1. Fasting with exogenous ketone salt supplement

2. Fasting with exogenous carbohydrate supplement

Study Timeline

• Study First Submitted: 2022-11-29
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-12
• Last Update Submitted: 2022-12-12
• Study First Posted: 2022-12-15
• Last Update Posted: 2022-12-15
• Study Start: 2022-12-16
• Primary Completion: 2023-12-16
• Study Completion: 2024-12-16

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Left ventricle ejection fraction by cardiac MRI under acute intake of exogenous ketone salt compared with exogenous carbohydrate placebo in heart failure patients.	15 minutes	Measure by Cardiac MR in pourcentage between diastolic and systolic volume in millimeter

Secondary Outcome Measures

Name	Time	Method
Ventricle volume by cardiac MRI after intake supplement in heart failure patients.	15 minutes	Measure by Cardiac MR in millimeter
Effects of supplement on serum biomarkers	60 minutes	Concentration of insulin (IU)
Right ventricle ejection fraction by cardiac MRI after intake supplement in heart failure patients.	15 minutes	Measure by Cardiac MR in pourcentage between diastolic and systolic volume in millimeter
Cardiac output by cardiac MRI after intake supplement in heart failure patients.	15 minutes	Measure by Cardiac MR in liter per minute
Effects of supplement on the blood pressure of heart failure patients	60 minutes	Measure the blood pressure in systole and diastole in mm Hg
Effects of supplement on the heart rate of heart failure patients	60 minutes	Measure the heart rate in beat per minute

Trial Locations

Locations (2)

Centre Hospitalier Universitaire de Sherbrooke, departement de médecine; 🇨🇦 Sherbrooke, Quebec, Canada

Centre Hospitalier Universitaire de Sherbrooke, departement de cardiologie; 🇨🇦 Sherbrooke, Quebec, Canada