Ketones, SGLT2, HFrEF

Recruiting now · Early Phase 1 · Has a placebo group

Conditions studied: Type2diabetes, Heart Failure With Reduced Ejection Fraction

In brief

The study team will examine the effects of elevated plasma ketone levels following initiation of SGLT2 inhibitor therapy in high-risk type 2 diabetes mellitus (T2DM) individuals with heart failure (HF) with reduced ejection fraction (HFrEF) providing an energy-rich fuel that is taken up with great avidity by the myocardium, to measure change in Left Ventricle diastolic and systolic function

Key facts

Study ID

NCT06229678

Run by

The University of Texas Health Science Center at San Antonio

People needed

71

Starts

2024-01-25

Expected to finish

2027-03-01

Last updated by the study team

2026-02-05

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 2 Diabetes Mellitus
• Class II-III New York Heart Association (NYHA) heart failure and reduced ejection fraction (EF) <50%
• Age 18-80 years
• BMI 23-44 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
• Only Type 2 diabetics treated with diet/exercise, metformin, sulfonylureas, metformin/sulfonylurea, Glucagon-like peptide-1 receptor agonist (GLP-1 RA), or insulin
• Stable body weight (±4 pounds) over the previous 3 months prior to enrollment
• Ability to understand study procedures and to comply with them for the entire length of the study.

You may not qualify if…

• Heart failure due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, severe valvular heart disease, hypertrophic obstructive cardiomyopathy.
• Significant change in diuretic management during the month prior to screening (defined by doubling of diuretic dose or addition of another heart failure medication)
• Type 2 Diabetics treated with Dipeptidyl Peptidase-4 Inhibitor (DPP4i) or pioglitazone
• Pregnancy, lactation, or plans to become pregnant. A negative pregnancy test will be performed before each MRI study to assess current status. For women of child-bearing age (WOCBA) willingness to use contraception, if applicable.
• Allergy/sensitivity to study drugs or their ingredients.
• Cancer.
• 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.

Where it is running

• Texas Diabetes Institute - University Health System — San Antonio, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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