The Hemodynamic Effects of SGLT2i in Acute Decompensated Heart Failure

Acute Decompensated Heart Failure Clinical Trial

Official title:

The Hemodynamic Effects of Sodium-Glucose Co-Transporter 2 Inhibitors (SGLT2i) in Acute Decompensated Heart Failure

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05346653
• Other study ID #: IRB22-0346
• Status: Terminated
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Acute Decompensated Heart Failure
• Heart Failure

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