Clinical trial NCT05346653: The Hemodynamic Effects of SGLT2i in Acute Decompensated Heart Failure
Official title: The Hemodynamic Effects of Sodium-Glucose Co-Transporter 2 Inhibitors (SGLT2i) in Acute Decompensated Heart Failure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Acute Decompensated Heart Failure
Keywords: SGLT2i
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Indirect Fick Cardiac Index
timeFrame: 4 days
measure: Change in Pulmonary Capillary Wedge Pressure (PCWP)
timeFrame: 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Jonathan Grinstein, MD
role: PRINCIPAL_INVESTIGATOR
References: