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

U

Université de Sherbrooke

Status

Completed

Conditions

Heart Failure

Treatments

Dietary Supplement: exogenous ketone salt supplement
Dietary Supplement: exogenous carbohydrate supplement

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05651529
2023-4720

Details and patient eligibility

About

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?

Full 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

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

20 participants in 2 patient groups, including a placebo group

Ketone
Active Comparator group
Treatment:
Dietary Supplement: exogenous ketone salt supplement
Placebo
Placebo Comparator group
Treatment:
Dietary Supplement: exogenous carbohydrate supplement

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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