Physiological Effects Ketone Ester in Heart
Not Applicable
Recruiting
- Conditions
- Heart Failure
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Ketone Ester
- Registration Number
- NCT05924802
- Lead Sponsor
- The Cleveland Clinic
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- heart failure EF < 40%
Exclusion Criteria
- Claustrophobia
- Contraindicated implanted device
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo given that mimics taste, weight, and size of the interventional supplement mirroring the same time points as the ketone ester supplement group. Mirrored imaging with MRI as well. Ketone ester supplement Ketone Ester Ketone ester given daily for 12 weeks and scanned before and after intervention with MRI.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Cardiovascular Innovation Research Center
🇺🇸Cleveland, Ohio, United States