Phase 4
N=32
HF Patients With LVADs Being Treated With SGLT2i
Heart Failure With Reduced Ejection Fraction
Bottom Line
View on ClinicalTrials.gov: NCT05278962 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Change in Left Ventricular End-diastolic Dimension (LVEDD) — -1.1; -0.9 centimeters (cm) — p=0.38
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- SGLT2i (Drug); No SGLT2i (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- Aug 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Left Ventricular End-diastolic Dimension (LVEDD) |
-1.1; -0.9 | 0.38 |
| SECONDARY Weight Change |
-1.2; 0.7 | — |
| SECONDARY Diuretic Dose |
80; 80 | — |
| SECONDARY LVEF (Left Ventricular Ejection Fraction) |
17.5; 18.55 | — |
| SECONDARY RV (Normal Right Ventricular) Size |
4.5; 3.8 | — |
| SECONDARY Creatitine |
1.03; 1.17 | — |
| SECONDARY ALT (Alanine Aminotransferase/SGPT) |
31; 14.5 | — |
| SECONDARY AST (Aspartate Aminotransferase/SGOT) |
30; 22.5 | — |
| SECONDARY Total Bilirubin (Bili) |
0.7; 0.55 | — |
| SECONDARY Alk Phos (Alkaline Phosphatase/ALP) |
124; 88.5 | — |
Summary
The main purpose of this study is to observe outcomes of sodium-glucose co-transporter 2 inhibitors (SGLT2i) in heart failure (HF) patients with left ventricular assist devices (LVAD).
Eligibility Criteria
Inclusion Criteria
- LVAD implantation
- Have not already been prescribed management with an SGLT2i
- Estimated glomerular filtration rate (eGFR) ≥ 30 milliliters(ml)/minute(min)/1.73 meter(m)2
- Age ≥ 18 years-old
- Able to provide informed consent
Exclusion Criteria
- Diagnosis of Type 1 diabetes mellitus
- eGFR < 30 ml/min/1.73 m2
- Age < 18 years-old
Data sourced from ClinicalTrials.gov (NCT05278962). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.