Health TrialsbyHealthPanel

Ketones, SGLT2, HFrEF

ConditionsType2diabetesHeart Failure With Reduced Ejection Fraction
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Empagliflozin 25 MG Oral Tablet

    Drug

    Empagliflozin 25MG will be administered orally once per day for 3 months

  • Placebo

    Drug

    The placebo will be administered orally once per day for 3 months

  • Acipimox 250 Mg Oral Capsule

    Drug

    subjects will be started on acipimox 250mg every 6 hours for 8 days while on continued empagliflozin/placebo therapy. This will be added at the end of 3 months after they finished baseline studies

Treatment groups

71 Participants
are divided into 2 treatment groups
Group A: Empagliflozin GroupExperimental treatment 2 interventions
Group B: Placebo groupPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change in Phosphocreatine

A measure of phosphocreatine change from baseline to study end

Time frame
Baseline to 3 months
2

Change in Adenosine Triphosphate (ATP)

A measure of ATP change from baseline to study end

Time frame
Baseline to 3 months
3

Change in Inorganic Phosphate

A measure of inorganic phosphate change from baseline to study end

Time frame
Baseline to 3 months
4

Change in Phosphodiester

A measure of phosphodiester change from baseline to study end

Time frame
Baseline to 3 months

Secondary outcomes

1

Plasma Beta-hydroxybutyrate (β-OH-B)

Change in β-OH-B with medication

Time frame
baseline to 3 months
2

Acetoacetate concentrations

Change in acetoacetate concentrations

Time frame
baseline to 3 months
3

6-min walking test

Change in the distance that can be covered in a 6 minute walk test

Time frame
baseline to 3 months
4

Patient-Reported Outcomes Measure Information System

By checking KCCQ (Kansas City Cardiomyopathy) scoring: Responses are categorized under 3 sub scales (symptom burden, physical limitation and quality of life) with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The total KCCQ score represents the mean of the three sub scale scores.

Time frame
baseline to 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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
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