Physiological Effects Ketone Ester in Heart (KEHeart)

NeuroTherapia, Inc.

Status: Active, not recruiting

Conditions: Heart Failure

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Ketone Ester

Study type: Interventional

Funder types: Other

Identifiers

NCT05924802

23-570

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• heart failure EF < 40%

Exclusion criteria

• Claustrophobia
• Contraindicated implanted device

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo

Ketone ester supplement

Experimental group

Description:

Ketone ester given daily for 12 weeks and scanned before and after intervention with MRI.

Treatment:

Dietary Supplement: Ketone Ester