Heart Failure Clinical Trial

The Hemodynamic Effects of SGLT2i in Acute Decompensated Heart Failure

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.

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Full 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.

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Eligibility Criteria

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
History of intolerance to SGLT2i medications
Patients listed for cardiac transplantation or on mechanical support
Pregnant or breastfeeding

Study is for people with:

Heart Failure

Phase:

Phase 4

Estimated Enrollment:

1

Study ID:

NCT05346653

Recruitment Status:

Terminated

Sponsor:

University of Chicago

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There is 1 Location for this study

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University of Chicago
Chicago Illinois, 60637, United States

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Study is for people with:

Heart Failure

Phase:

Phase 4

Estimated Enrollment:

1

Study ID:

NCT05346653

Recruitment Status:

Terminated

Sponsor:


University of Chicago

How clear is this clinincal trial information?

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