Ketones, SGLT2, HFrEF
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe University of Texas Health Science Center at San Antonio
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Empagliflozin 25 MG Oral Tablet
- Placebo
- Acipimox 250 Mg Oral Capsule
Treatment groups
71 Participants
are divided into 2 treatment groupsLocations
1Texas Diabetes Institute - University Health System78207, San AntonioTexas, United States
Sponsors and collaborators
The University of Texas Health Science Center at San Antonio
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov