Effects of a two-week ketogenic diet on heart function in patients with heart failure
Effects of 2-week Ketosis on Myocardial Ketone Body Consumption, Utilization, and External Efficiency in Patients With Chronic Heart Failure
NA · Aarhus University Hospital · NCT06398964
This study tests if a two-week ketogenic diet can improve heart function in people with heart failure by helping their hearts use a different type of energy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | Aarhus University Hospital (other) |
| Locations | 1 site (Aarhus, Region Midtjylland) |
| Trial ID | NCT06398964 on ClinicalTrials.gov |
What this trial studies
This study investigates how a two-week ketogenic diet impacts the heart's ability to utilize ketone bodies for energy in patients suffering from chronic heart failure with reduced ejection fraction. The research focuses on measuring the consumption and efficiency of ketone bodies, specifically 3-hydroxybutyrate, as an alternative energy source for the heart. By comparing the effects of a ketogenic diet to an isocaloric placebo drink, the study aims to determine potential improvements in heart function and overall patient outcomes. The findings could provide insights into new dietary interventions for managing heart failure.
Who should consider this trial
Good fit: Ideal candidates for this study are patients under 55 years old with diabetes or elevated HbA1c levels and significant cardiac conditions.
Not a fit: Patients with chronic heart failure classified as NYHA class II-III or with a left ventricular ejection fraction below 40% may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to dietary recommendations that improve heart function and quality of life for patients with heart failure.
How similar studies have performed: While there is emerging research on the benefits of ketone bodies in heart failure, this specific approach is relatively novel and has not been extensively tested in clinical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diabetes or HbA1c \> 48 mmol/L * significant cardiac valve disease * severe stable angina pectoris * severe comorbidity as judged by the investigator * inability to give informed consent * Age \<55 years * Other disease or treatment making subject unsuitable for study participation as judged by the investigator Exclusion Criteria: * Chronic heart failure * NYHA class II-III * left ventricular ejection fraction (LVEF) \<40% * Negative urine-HCG for women with childbearing potential
Where this trial is running
Aarhus, Region Midtjylland
- Aarhus University Hospital — Aarhus, Region Midtjylland, Denmark (RECRUITING)
Study contacts
- Principal investigator: Henrik Henrik, Professor — Aarhus University Hospital
- Study coordinator: Niels Jespersen, MD
- Email: nijesp@rm.dk
- Phone: +45 22950990
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure With Reduced Ejection Fraction