The Hemodynamic Effects of SGLT2i in Acute Decompensated Heart Failure
NCT ID: NCT05346653
Last Updated: 2024-09-04
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
1 participants
INTERVENTIONAL
2023-05-22
2023-05-23
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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)
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
Interventions
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SGLT2i
dapagliflozin (10 mg daily)
No SGLT2i
No SGLT2i
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Jonathan Grinstein, MD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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University of Chicago
Chicago, Illinois, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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IRB22-0346
Identifier Type: -
Identifier Source: org_study_id
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