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โ† Trials
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Ketones, SGLT2, HFrEF

RecruitingEARLY Phase 1Ages 18 Years - 70 YearsAllThe University of Texas Health Science Center at โ€ฆ
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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) โ‰ค 145/85 mmHg * Estimated glomerular filtration rate (eGFR) โ‰ฅ30 ml/minโ€ข1.73 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 (ยฑ4 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. Exclusion Criteria: * 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.
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What it tests

  • Empagliflozin 25 MG Oral Tablet
  • Placebo
  • Acipimox 250 Mg Oral Capsule
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Where

1 site
Texas Diabetes Institute - University Health System
San Antonio, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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