Physiological Effects Ketone Ester in Heart

Not Applicable

Recruiting

• Conditions: Heart Failure

• 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

Study Timeline

• Study First Submitted: 2023-06-09
• Study First Submitted QC: 2023-06-27
• Study First Posted: 2023-06-29
• Study Start: 2024-06-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21
• Primary Completion: 2028-09
• Study Completion: 2029-09

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

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