RecruitingType2diabetesHeart Failure With Reduced Ejection Fraction
Ketones, SGLT2, HFrEF
Eligible age
18–70 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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
Sponsor: The University of Texas Health Science Center at San Antonio
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
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's recruiting
Texas
San Antonio
Source: ClinicalTrials.gov · NCT06229678 · last updated 2026-02-05