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Active, Not Recruiting

NCT Number: NCT05924802

Physiological Effects Ketone Ester in Heart

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiovascular Innovation Research Center

Cleveland, Ohio, 44195, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • heart failure EF < 40%

Exclusion criteria

  • Claustrophobia
  • Contraindicated implanted device

Treatment and study plan

Ketone ester

Dietary Supplement

Added to water or lemonade 3 times per day.

Other names: delta G

Placebo

Dietary Supplement

Added to water or lemonade 3 times per day.

Primary outcomes

  1. Change in Left Ventricular Ejection Fraction

    Time frame: 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 outcomes

  1. Change in Creatine concentration

    Time frame: Pre-intervention and up to 12 weeks after intervention

    Measured with cardiac MRI the creatine concentration at two points and then delta is calculated

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Physiological Effects of Dietary Supplement Ketone Ester on the Heart

Acronym: KEHeart

Important dates

Study start
2024
Primary completion
2026
Study completion
2029
First posted
Jun 29, 2023
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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