Clinical trial NCT05651529: Acute Oral Ketones or Carbohydrate Supplement Modify Heart Function in Heart Failure?
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?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Keywords: Ketones
Heart
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Nestlé Health Science Spain
First posted: 2022-12-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover Assignment, Each participant will have to do the 2 Acute supplementation interventions
Primary purpose: BASIC_SCIENCE

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

Eligibility criteria: 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

Primary outcomes:
measure: Left ventricle ejection fraction by cardiac MRI under acute intake of exogenous ketone salt compared with exogenous carbohydrate placebo in heart failure patients.
timeFrame: 15 minutes
Secondary outcomes:
measure: Right ventricle ejection fraction by cardiac MRI after intake supplement in heart failure patients.
timeFrame: 15 minutes
measure: Ventricle volume by cardiac MRI after intake supplement in heart failure patients.
timeFrame: 15 minutes
measure: Cardiac output by cardiac MRI after intake supplement in heart failure patients.
timeFrame: 15 minutes
measure: Effects of supplement on serum biomarkers
timeFrame: 60 minutes
measure: Effects of supplement on serum biomarkers
timeFrame: 60 minutes
measure: Effects of supplement on serum biomarkers
timeFrame: 60 minutes
measure: Effects of supplement on serum biomarkers
timeFrame: 60 minutes
measure: Effects of supplement on serum biomarkers
timeFrame: 60 minutes
measure: Effects of supplement on serum biomarkers
timeFrame: 60 minutes
measure: Effects of supplement on the blood pressure of heart failure patients
timeFrame: 60 minutes
measure: Effects of supplement on the heart rate of heart failure patients
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke, departement de cardiologie
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke, departement de médecine
state: Quebec
Study officials:
References: