HF Patients With LVADs Being Treated With SGLT2i

Study Overview
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Brief Summary
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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
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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.

Official Title
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Heart Failure Patients With Left Ventricular Assist Devices Being Treated With Sodium-Glucose Co-Transporter 2 Inhibitors

Conditions
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Heart Failure With Reduced Ejection Fraction

Intervention / Treatment
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* Drug: SGLT2i
* Other: No SGLT2i


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SGLT2i<br>Participants will be asked to take an SGLT2i for 6 months. The SGLT2i and heart failure care will be managed according to routine care, and data will be collected from the participant's medical record. | Drug: SGLT2i<br>* empagliflozin (10 mg daily) or dapagliflozin (10 mg daily), depending on formulary coverage<br>|
| Active Comparator: No SGLT2i<br>Participants will not be asked to take an SGLT2i. Heart failure care will be managed according to routine care, and data will be collected from the participant's medical record. | Other: No SGLT2i<br>* No SGLT2i<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of ramp stages needed to achieve hemodynamic optimization | Measured by echocardiography | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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left ventricular assist device, SGLT2i