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Completed

NCT Number: NCT05651529

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

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?

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Key information

Conditions

Heart Failure Acid-Base Imbalance Acidosis Cardiovascular Diseases Heart Diseases Ketosis Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Sherbrooke, departement de cardiologie, Sherbrooke, Quebec, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exogenous ketone salt supplement

Dietary 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.

Other names: Post-Prandial with exogenous ketone salt supplement

exogenous carbohydrate supplement

Dietary Supplement

Dietary Supplement: Fasting water and with exogenous carbohydrate supplement. Participants will have to take 1 doses of supplement 30 minutes before the scan.

Other names: Post-Prandial with exogenous carbohydrate supplement

Primary outcomes

  1. Left ventricle ejection fraction by cardiac MRI under acute intake of exogenous ketone salt compared with exogenous carbohydrate placebo in heart failure patients.

    Time frame: 15 minutes

    Measure by Cardiac MR in pourcentage between diastolic and systolic volume in millimeter

Secondary outcomes

  1. Right ventricle ejection fraction by cardiac MRI after intake supplement in heart failure patients.

    Time frame: 15 minutes

    Measure by Cardiac MR in pourcentage between diastolic and systolic volume in millimeter

  2. Ventricle volume by cardiac MRI after intake supplement in heart failure patients.

    Time frame: 15 minutes

    Measure by Cardiac MR in millimeter

  3. Cardiac output by cardiac MRI after intake supplement in heart failure patients.

    Time frame: 15 minutes

    Measure by Cardiac MR in liter per minute

  4. Effects of supplement on serum biomarkers

    Time frame: 60 minutes

    Concentration of lactate (mmol/L)

  5. Effects of supplement on serum biomarkers

    Time frame: 60 minutes

    Concentration sodium (mEq/L)

  6. Effects of supplement on serum biomarkers

    Time frame: 60 minutes

    Concentration of N-terminal pro-B-type natriuretic peptide (NT-proBNP) (pg/ml)

  7. Effects of supplement on serum biomarkers

    Time frame: 60 minutes

    Concentration of Beta-Hydroxybutyrate (mmol/L)

  8. Effects of supplement on serum biomarkers

    Time frame: 60 minutes

    Concentration of glucose (mmol/L)

  9. Effects of supplement on serum biomarkers

    Time frame: 60 minutes

    Concentration of insulin (IU)

  10. Effects of supplement on the blood pressure of heart failure patients

    Time frame: 60 minutes

    Measure the blood pressure in systole and diastole in mm Hg

  11. Effects of supplement on the heart rate of heart failure patients

    Time frame: 60 minutes

    Measure the heart rate in beat per minute

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

  • Nestlé Health Science

Registry information

Official study 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?

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 15, 2022
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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