The Hemodynamic Effects of SGLT2i in Acute Decompensated Heart Failure
The Hemodynamic Effects of Sodium-Glucose Co-Transporter 2 Inhibitors (SGLT2i) in Acute Decompensated Heart Failure
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Illinois
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Chicago, Illinois, United States, 60637
- University Of Chicago
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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.
|
dapagliflozin (10 mg daily)
|
|
Active Comparator: 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Indirect Fick Cardiac Index
Time Frame: 4 days
|
Measured by pulmonary artery catheter
|
4 days
|
|
Change in Pulmonary Capillary Wedge Pressure (PCWP)
Time Frame: 4 days
|
Measured by pulmonary artery catheter
|
4 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jonathan Grinstein, MD, University Of Chicago
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB22-0346
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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