Acute Decompensated Heart Failure
Conditions
Keywords
SGLT2i
Brief summary
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
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.
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. Age \> 18 years old 2. Heart Failure Reduced ejection fraction (HFrEF) of 40 or less 3. Estimated glomerular filtration rate (eGFR) \> 30milliliters(ml)/minute(min)/1.73 meter(m)2 4. Admitted to CCU by advanced heart failure service for decompensated heart failure requiring continuous hemodynamic monitoring with a pulmonary artery catheter
Exclusion criteria
1. Diagnosis of type 1 diabetes mellitus 2. eGFR \< 30ml/min/1.73m2 3. age \< 18 years old 4. Jehovah's witnesses 5. Diagnosis of group 1 pulmonary arterial hypertension 6. Insulin requirement above standard low dose sliding scale 7. Patients with a history of diabetic ketoacidosis (DKA) 8. Allergies to SGLT2i medications 9. History of intolerance to SGLT2i medications 10. Patients listed for cardiac transplantation or on mechanical support 11. Pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Indirect Fick Cardiac Index | 4 days | Measured by pulmonary artery catheter |
| Change in Pulmonary Capillary Wedge Pressure (PCWP) | 4 days | Measured by pulmonary artery catheter |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SGLT2i 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.
SGLT2i: dapagliflozin (10 mg daily) | 0 |
| No SGLT2i 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.
No SGLT2i: No SGLT2i | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Change in Indirect Fick Cardiac Index
Measured by pulmonary artery catheter
Time frame: 4 days
Population: Only 1 subject consented to the study and was not eligible for randomization.
Primary
Change in Pulmonary Capillary Wedge Pressure (PCWP)
Measured by pulmonary artery catheter
Time frame: 4 days
Population: Only 1 subject consented to the study and was not eligible for randomization.