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

Sponsor
Université de Sherbrooke (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05651529
Collaborator
Nestlé Health Science Spain (Industry)
20
Enrollment
2
Locations
24
Anticipated Duration (Months)
10
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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?

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: exogenous ketone salt supplement
  • Dietary Supplement: exogenous carbohydrate supplement
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Crossover Assignment, Each participant will have to do the 2 Acute supplementation interventionsCrossover Assignment, Each participant will have to do the 2 Acute supplementation interventions
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Triple (Participant, Investigator, Outcomes Assessor) Investigators, participants and outcome assessors will be fully blinded.
Primary Purpose:
Basic Science
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?
Anticipated Study Start Date :
Dec 16, 2022
Anticipated Primary Completion Date :
Dec 16, 2023
Anticipated Study Completion Date :
Dec 16, 2024

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. Ventricle volume by cardiac MRI after intake supplement in heart failure patients. [15 minutes]

    Measure by Cardiac MR in millimeter

  3. Cardiac output by cardiac MRI after intake supplement in heart failure patients. [15 minutes]

    Measure by Cardiac MR in liter per minute

  4. Effects of supplement on serum biomarkers [60 minutes]

    Concentration of lactate (mmol/L)

  5. Effects of supplement on serum biomarkers [60 minutes]

    Concentration sodium (mEq/L)

  6. Effects of supplement on serum biomarkers [60 minutes]

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

  7. Effects of supplement on serum biomarkers [60 minutes]

    Concentration of Beta-Hydroxybutyrate (mmol/L)

  8. Effects of supplement on serum biomarkers [60 minutes]

    Concentration of glucose (mmol/L)

  9. Effects of supplement on serum biomarkers [60 minutes]

    Concentration of insulin (IU)

  10. Effects of supplement on the blood pressure of heart failure patients [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 [60 minutes]

    Measure the heart rate in beat per minute

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier Universitaire de Sherbrooke, departement de cardiologie Sherbrooke Quebec Canada J1H 5N4
2 Centre Hospitalier Universitaire de Sherbrooke, departement de médecine Sherbrooke Quebec Canada J1H 5N4

Sponsors and Collaborators

  • Université de Sherbrooke
  • Nestlé Health Science Spain

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT05651529
Other Study ID Numbers:
  • 2023-4720
First Posted:
Dec 15, 2022
Last Update Posted:
Dec 15, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Université de Sherbrooke
Ketones
Heart
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of Dec 15, 2022