Study Stopped
Enrollment goals were not met.
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
1 other identifier
interventional
1
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started May 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2022
CompletedFirst Posted
Study publicly available on registry
April 26, 2022
CompletedStudy Start
First participant enrolled
May 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 23, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 23, 2023
CompletedResults Posted
Study results publicly available
December 6, 2023
CompletedSeptember 4, 2024
August 1, 2024
1 day
April 20, 2022
November 15, 2023
August 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
SGLT2i
ACTIVE COMPARATORParticipants 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.
No SGLT2i
ACTIVE COMPARATORParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Chicago
Chicago, Illinois, 60637, United States
Results Point of Contact
- Title
- Sr. Compliance Specialist
- Organization
- University of Chicago
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Grinstein, MD
University of Chicago
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2022
First Posted
April 26, 2022
Study Start
May 22, 2023
Primary Completion
May 23, 2023
Study Completion
May 23, 2023
Last Updated
September 4, 2024
Results First Posted
December 6, 2023
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share