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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05346653
Other study ID # IRB22-0346
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date May 22, 2023
Est. completion date May 23, 2023

Study information

Verified date November 2023
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date May 23, 2023
Est. primary completion date May 23, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
SGLT2i
dapagliflozin (10 mg daily)
Other:
No SGLT2i
No SGLT2i

Locations

Country Name City State
United States University of Chicago Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Indirect Fick Cardiac Index Measured by pulmonary artery catheter 4 days
Primary Change in Pulmonary Capillary Wedge Pressure (PCWP) Measured by pulmonary artery catheter 4 days
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