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The Hemodynamic Effects of SGLT2i in Acute Decompensated Heart Failure

Primary Purpose

Acute Decompensated Heart Failure

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
SGLT2i
No SGLT2i
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Decompensated Heart Failure focused on measuring SGLT2i

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of ChicagoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

SGLT2i

No SGLT2i

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Indirect Fick cardiac index
Measured by pulmonary artery catheter
Change in pulmonary capillary wedge pressure (PCWP)
Measured by pulmonary artery catheter

Secondary Outcome Measures

Full Information

First Posted
April 20, 2022
Last Updated
May 30, 2023
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT05346653
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 22, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Decompensated Heart Failure
Keywords
SGLT2i

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SGLT2i
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No SGLT2i
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
SGLT2i
Intervention Description
dapagliflozin (10 mg daily)
Intervention Type
Other
Intervention Name(s)
No SGLT2i
Intervention Description
No SGLT2i
Primary Outcome Measure Information:
Title
Change in Indirect Fick cardiac index
Description
Measured by pulmonary artery catheter
Time Frame
4 days
Title
Change in pulmonary capillary wedge pressure (PCWP)
Description
Measured by pulmonary artery catheter
Time Frame
4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Belkin, MD
Phone
773-702-9500
Email
Mark.Belkin@uchospitals.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Grinstein, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Belkin, MD
Phone
773-702-9500
Email
Mark.Belkin@uchospitals.edu
First Name & Middle Initial & Last Name & Degree
Jonathan Grinstein, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Hemodynamic Effects of SGLT2i in Acute Decompensated Heart Failure

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