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Oral Ketones for Heart Failure

Phase < 1

Recruiting

Led By Carolina Solis-Herrera, MD

Research Sponsored by The University of Texas Health Science Center at San Antonio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age = 18-80 years

Be older than 18 years old

Must not have

Allergy/sensitivity to study drugs or their ingredients

Major organ or metabolic diseases, or physical limitations that will not allow the subject to complete the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1.5 hours to 24 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial will study if taking ketone esters can improve heart function in people with T2DM and heart failure.

Who is the study for?

Adults aged 18-80 with Type 2 Diabetes and Heart Failure (HFrEF), having a BMI of 23-38, stable heart medications, and functioning kidneys. Women must agree to use contraception. Excluded are those with recent cardiovascular events, certain drug treatments for diabetes or heart issues, pregnancy, substance abuse problems, major diseases that limit study participation or a history of cancer (except certain skin cancers in remission).

What is being tested?

The trial is testing the effects of an oral supplement called Ketone Monoester on heart function in patients with both Type 2 Diabetes and HFrEF. It aims to understand if this supplement can change how the heart works by providing it with ketones that don't rely on insulin.

What are the potential side effects?

While specific side effects are not listed here, potential risks may include allergic reactions to ingredients in the Ketone Monoester or other unforeseen responses due to its interaction with existing conditions like diabetes and HFrEF.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not allergic to the drugs or their ingredients used in the study.

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I do not have major organ diseases or physical limitations that would prevent me from completing the study.

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I am not taking any medications that could worsen heart function or blood sugar control.

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I have not had a heart attack or stroke in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1.5 hours to 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1.5 hours to 24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1.5 hours to 24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cardiac Efficiency after acute dose (Left-ventricular function)

Cardiac Efficiency after chronic dosing (Left-ventricular function)

Secondary study objectives

Acetoacetate

Beta-hydroxybutyrate

Free Fatty Acids (FFAs)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ketone Ester administrationExperimental Treatment1 Intervention

1. Monitored administration of oral Ketone monoester at 400mg/kg dosed twice on visit 2 (cardiac MRI day) 2. Self administered oral β-hydroxybutyrate (BOHB) at 400mg/kg/day for a period of 6 days

0 / 5Eligibility criteria met