Heart Failure With Reduced Ejection Fraction
Conditions
Keywords
left ventricular assist device, SGLT2i
Brief 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).
Detailed description
The exact mechanism of cardiovascular benefit from SGLT2i continues to be the source of further research. The investigators hypothesize that heart failure patients with LVADs will similarly benefit from the SGLT2i-associated natriuresis and diuresis, which in turn reduces preload. This is further associated with reduced heart failure readmissions and right ventricular failure. Additionally, the animal models indicating reduced cardiac work and remodeling in this population may benefit these patients as one of the goals of LVAD implantation is to reduce cardiac energy expenditure and promote remodeling and recovery in these patients. This is a prospective, randomized controlled study to assess cardiac benefit of SGLT2i in 40 consecutive patients with heart failure undergoing LVAD implantation. After routine LVAD implantation, patients will be randomized 1:1 to one of two routine care arms: management with an SGLT2i \[empagliflozin 10 milligram (mg) daily or dapagliflozin 10 mg daily, based on formulary coverage\] or no SGLT2i. The patient's treating physician will be able to override randomization assignment if they determine that the assignment is not in the patient's best interest. SGLT2i management (if applicable) and follow-up care will be dictated by routine care. Data will be collected from the subject's medical record for 6 months.
Interventions
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. LVAD implantation 2. Have not already been prescribed management with an SGLT2i 3. Estimated glomerular filtration rate (eGFR) ≥ 30 milliliters(ml)/minute(min)/1.73 meter(m)2 4. Age ≥ 18 years-old 5. Able to provide informed consent
Exclusion criteria
1. Diagnosis of Type 1 diabetes mellitus 2. eGFR \< 30 ml/min/1.73 m2 3. Age \< 18 years-old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in number of ramp stages needed to achieve hemodynamic optimization | 6 months | Measured by echocardiography |
Countries
United States
Outcome results
None listed