Heart Failure
Conditions
Brief summary
The study is aimed to phenotype with cardiac MRI the physiological effects of ketone esters on the heart. Patients with heart failure will be recruited and given ketone esters or placebo in a randomized fashion. Cardiac MRI will be performed at baseline and after 12weeks follow up.
Interventions
DIETARY_SUPPLEMENTKetone Ester
Added to water or lemonade 3 times per day.
DIETARY_SUPPLEMENTPlacebo
Added to water or lemonade 3 times per day.
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
Both participant and investigators will be blinded. A representative in the center will be in charge of maintaining encrypted key.
Intervention model description
Placebo vs intervention group. Ketone ester is NOT a drug and only used to see the physiological effects on the heart.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* heart failure EF \< 40%
Exclusion criteria
* Claustrophobia * Contraindicated implanted device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Left Ventricular Ejection Fraction | Pre-intervention and up to 12 weeks after intervention | Measured with cardiac MRI the left ventricular ejection fraction at two points and then delta is calculated |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Creatine concentration | Pre-intervention and up to 12 weeks after intervention | Measured with cardiac MRI the creatine concentration at two points and then delta is calculated |
Countries
United States
Outcome results
None listed