TerminatedPhase 4

The Hemodynamic Effects of SGLT2i in Acute Decompensated Heart Failure

Stopped: Enrollment goals were not met.

United States1 participantsStarted 2023-05-22

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Change in Indirect Fick Cardiac Index

Timeframe: 4 days

Change in Pulmonary Capillary Wedge Pressure (PCWP)

Timeframe: 4 days

Trial details

NCT IDNCT05346653

SponsorUniversity of Chicago

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-23

Results submitted2023-11-15

View on ClinicalTrials.gov More Acute Decompensated Heart Failure trials