No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
10 (estimated)
Sponsor
The University of Texas Health Science Center at San Antonio · Other
Who this trial is looking for
This trial is looking for adults with heart failure and diabetes to see if oral ketones can improve heart function. Participants must be stable on heart failure medications and meet certain health criteria.
Are You a Good Fit for This Trial?
Must not be takingSGLT2i medications
You may be able to join if
I am between 18 and 80 years old.
I have heart failure.
I have type 2 diabetes.
I have a stable dose of heart failure medications.
My blood pressure is less than 145/85 mmHg.
My BMI is between 23 and 38.
My blood sugar test is between 6.0% and 10.0%.
I am willing to use contraception if I am a woman of child-bearing age.
You may not be able to join if
I have taken heart medications that might worsen my condition.
I am pregnant, breastfeeding, or planning to become pregnant.
I am allergic to the study drugs.
I misuse drugs or alcohol.
I cannot provide written consent.
I have had cancer in the last 5 years (except certain skin cancers).
I have had a cardiovascular event in the last 3 months.
I have major organ diseases or physical limitations that affect my participation.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This study will provide insight into whether cardiac function changes with oral Ketone Esters (KE) administered to patients with Type 2 Diabetes Mellitus (T2DM) and Heart failure with reduced ejection fraction (HFrEF). Plasma ketones are avidly extracted by cardiac muscle and their uptake is not dependent upon insulin or influenced by insulin resistance.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Subjects must be on a stable dose of guideline-directed medications for Heart Failure (HF).
* Patients will have an established diagnosis of HF before the screening visit, documented by an acceptable imaging modality in the last 6 months.
* Age = 18-80 y
* Body Mass Index (BMI…
Inclusion Criteria:
* Subjects must be on a stable dose of guideline-directed medications for Heart Failure (HF).
* Patients will have an established diagnosis of HF before the screening visit, documented by an acceptable imaging modality in the last 6 months.
* Age = 18-80 y
* Body Mass Index (BMI) =23-38 kg/m2
* Glycated hemoglobin (HbA1c) = 6.0-10.0%
* Blood Pressure (BP) \< 145/85 mmHg
* Estimated Glomerular Filtration Rate (eGFR) \> 30 ml/min•1.73 m2
* For women of child-bearing age (WOCBA) willingness to use contraception, if applicable.
Exclusion Criteria:
* Patients treated with Sodium-Glucose Transport Protein (SGLT2i's) or medications that may impair heart function or acutely worsen glycemic control will be excluded.
* Pregnancy, lactation, or plans to become pregnant. A negative pregnancy test will be performed before each Magnetic resonance imaging (MRI) study to assess current status.
* Allergy/sensitivity to study drugs or their ingredients.
* Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
* Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
* Subjects with a history of cancer (except basal or squamous cell cancer that has been resolved/remission for 5 years)
* Cardiovascular event within the last 3 months
* Major organ or metabolic diseases, or physical limitations that will not allow the subject to complete the study.
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