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Ketone Supplement for Heart Failure

N/A
Recruiting
Led By Yuchi Han, MD, MMSc
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years old and ≤ 80 years old
Be older than 18 years old
Must not have
History of uncontrolled or untreated ventricular arrhythmias
Women who are pregnant, current breast-feeding, or have intention to become pregnant while in the trial
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 weeks, 10 weeks, 16 weeks

Summary

This trial tests if a ketone drink can help heart failure patients. It compares it to a placebo drink.

Who is the study for?
Adults aged 18-80 with heart failure, BMI of 25-50 or Type II Diabetes/prediabetes, stable heart and diabetes medications for at least 3 months, and able to do treadmill tests. Excludes those with recent major surgeries, certain heart conditions like transplants or severe arrhythmias, pregnant women, drug/alcohol abuse history, severe kidney disease, uncontrolled blood pressure or life expectancy less than a year.
What is being tested?
The trial is testing the effects of a ketone ester beverage on exercise tolerance and cardiac function in people with heart failure. Participants will be randomly assigned to receive either the ketone ester drink or a placebo (a non-ketone standard beverage) to compare outcomes.
What are the potential side effects?
Potential side effects may include gastrointestinal discomfort due to supplement intake. Since it's not specified for this trial's supplements specifically, common side effects from similar products can include nausea, stomach upset or an unpleasant taste.

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 have a history of irregular heartbeats that haven't been controlled or treated.
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I am not pregnant, breastfeeding, nor plan to become pregnant during the trial.
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I have Type I diabetes.
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I have had diabetic ketoacidosis in the past.
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I need oxygen therapy for a lung condition.
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I have had or will have a heart procedure to improve blood flow within the last or next 30 days.
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I have severe heart artery problems that haven't been fixed by surgery.
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I have a specific heart condition like amyloidosis or muscular dystrophy.
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My liver tests are more than three times the normal limit.
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I am willing and able to follow the supplement guidelines.
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My kidney function is very low, with an eGFR under 30.
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I am currently taking SGLT2 inhibitors for my condition.
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I have severe heart valve issues likely needing surgery soon.
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I have heart or blood vessel conditions that could affect my health unpredictably.
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I have ongoing irregular heartbeats.
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I have had a heart transplant or am on the waiting list for one.
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I needed strong heart failure medication or mechanical support recently.
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I have not had, nor am I scheduled for, major surgery around the time of screening.
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I have had severe low potassium levels below 3.0 mg/dL.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 weeks, 10 weeks, 16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks, 10 weeks, 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in maximal exercise performance
Secondary study objectives
B-natriuretic peptide (BNP)
Change in CMR measures of cardiac function
Change in Cardiac function after acute ingestion of KE or placebo
+4 more
Other study objectives
Change in fat storage
Change in stiffness

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Ketone EsterExperimental Treatment1 Intervention
This arm will provide a Keto Ester Beverage for consumption.
Group II: Keto Ester AcuteExperimental Treatment1 Intervention
This arm will provide a Keto Ester Beverage for consumption.
Group III: PlaceboPlacebo Group1 Intervention
This arm will provide a Placebo Beverage for consumption.
Group IV: Placebo AcutePlacebo Group1 Intervention
This arm will provide a Placebo Beverage for consumption.

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
866 Previous Clinical Trials
655,131 Total Patients Enrolled
12 Trials studying Metabolic Syndrome
1,059 Patients Enrolled for Metabolic Syndrome
Yuchi Han, MD, MMScPrincipal InvestigatorOhio State University
1 Previous Clinical Trials
90 Total Patients Enrolled
~17 spots leftby Aug 2026
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