The Hemodynamic Effects of SGLT2i in Acute Decompensated Heart Failure

Study Overview
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Brief Summary
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The main purpose of this study is to observe hemodynamic effects of initiating sodium-glucose co-transporter 2 inhibitors (SGLT2i) in patients admitted to the intensive care unit (ICU) with acute decompensated heart failure.

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 acute decompensated heart failure will similarly benefit from the SGLT2i-associated natriuresis and diuresis. This mechanism should improve invasive hemodynamics during an inpatient ICU stay. This is a prospective, randomized controlled study to assess cardiac benefit of SGLT2i in 40 consecutive patients admitted to University of Chicago Cardiac Intensive Care Unit (CCU) Advanced Heart Failure Service. Subjects will be randomized 1:1 to one of two routine care arms: treatment with an SGLT2i [dapagliflozin 10 mg daily] or no SGLT2i. After randomization, your SGLT2i and heart failure care will be managed according to routine care, and the investigators will collect the subject's medical data. 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.

Official Title
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The Hemodynamic Effects of Sodium-Glucose Co-Transporter 2 Inhibitors (SGLT2i) in Acute Decompensated Heart Failure

Conditions
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Acute Decompensated Heart Failure

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: Age > 18 years old Heart Failure Reduced ejection fraction (HFrEF) of 40 or less Estimated glomerular filtration rate (eGFR) > 30milliliters(ml)/minute(min)/1.73 meter(m)2 Admitted to CCU by advanced heart failure service for decompensated heart failure requiring continuous hemodynamic monitoring with a pulmonary artery catheter Exclusion Criteria: Diagnosis of type 1 diabetes mellitus eGFR < 30ml/min/1.73m2 age < 18 years old Jehovah's witnesses Diagnosis of group 1 pulmonary arterial hypertension Insulin requirement above standard low dose sliding scale Patients with a history of diabetic ketoacidosis (DKA) Allergies to SGLT2i medications History of intolerance to SGLT2i medications Patients listed for cardiac transplantation or on mechanical support Pregnant or breastfeeding

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 treated with a SGLT2i during their ICU stay. 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>* dapagliflozin (10 mg daily)<br>|
| Active Comparator: No SGLT2i<br>Participants will not be treated with a SGLT2i during their ICU stay. 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 Indirect Fick Cardiac Index | Measured by pulmonary artery catheter | 4 days | 
| Change in Pulmonary Capillary Wedge Pressure (PCWP) | Measured by pulmonary artery catheter | 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SGLT2i