The Hemodynamic Effects of SGLT2i in Acute Decompensated Heart Failure

Phase 4

Terminated

• Conditions: Acute Decompensated Heart Failure
• Interventions: Drug: SGLT2i; Other: No SGLT2i

• Registration Number: NCT05346653
• Lead Sponsor: University of Chicago

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.

Study Timeline

• Study First Submitted: 2022-04-20
• Study First Submitted QC: 2022-04-20
• Study First Posted: 2022-04-26
• Study Start: 2023-05-22
• Primary Completion: 2023-05-23
• Study Completion: 2023-05-23
• Status Verified: 2023-11
• Results First Submitted: 2023-11-15
• Results First Submitted QC: 2023-11-15
• Last Update Submitted: 2023-11-15
• Results First Posted: 2023-12-06
• Last Update Posted: 2023-12-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SGLT2i	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.
No SGLT2i	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.

Primary Outcome Measures

Name	Time	Method
Change in Indirect Fick Cardiac Index	4 days	Measured by pulmonary artery catheter
Change in Pulmonary Capillary Wedge Pressure (PCWP)	4 days	Measured by pulmonary artery catheter

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States