HF Patients With LVADs Being Treated With SGLT2i
Primary Purpose
Heart Failure With Reduced Ejection Fraction
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
SGLT2i
No SGLT2i
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure With Reduced Ejection Fraction focused on measuring left ventricular assist device, SGLT2i
Eligibility Criteria
Inclusion Criteria:
- LVAD implantation
- Have not already been prescribed management with an SGLT2i
- Estimated glomerular filtration rate (eGFR) ≥ 30 milliliters(ml)/minute(min)/1.73 meter(m)2
- Age ≥ 18 years-old
- Able to provide informed consent
Exclusion Criteria:
- Diagnosis of Type 1 diabetes mellitus
- eGFR < 30 ml/min/1.73 m2
- Age < 18 years-old
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 asked to take an SGLT2i for 6 months. 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 asked to take an SGLT2i. 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 number of ramp stages needed to achieve hemodynamic optimization
Measured by echocardiography
Secondary Outcome Measures
Full Information
NCT ID
NCT05278962
First Posted
March 4, 2022
Last Updated
September 15, 2023
Sponsor
University of Chicago
1. Study Identification
Unique Protocol Identification Number
NCT05278962
Brief Title
HF Patients With LVADs Being Treated With SGLT2i
Official Title
Heart Failure Patients With Left Ventricular Assist Devices Being Treated With Sodium-Glucose Co-Transporter 2 Inhibitors
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 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 outcomes of sodium-glucose co-transporter 2 inhibitors (SGLT2i) in heart failure (HF) patients with left ventricular assist devices (LVAD).
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 LVADs will similarly benefit from the SGLT2i-associated natriuresis and diuresis, which in turn reduces preload. This is further associated with reduced heart failure readmissions and right ventricular failure. Additionally, the animal models indicating reduced cardiac work and remodeling in this population may benefit these patients as one of the goals of LVAD implantation is to reduce cardiac energy expenditure and promote remodeling and recovery in these patients.
This is a prospective, randomized controlled study to assess cardiac benefit of SGLT2i in 40 consecutive patients with heart failure undergoing LVAD implantation. After routine LVAD implantation, patients will be randomized 1:1 to one of two routine care arms: management with an SGLT2i [empagliflozin 10 milligram (mg) daily or dapagliflozin 10 mg daily, based on formulary coverage] or no SGLT2i. 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. SGLT2i management (if applicable) and follow-up care will be dictated by routine care. Data will be collected from the subject's medical record for 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Reduced Ejection Fraction
Keywords
left ventricular assist device, SGLT2i
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SGLT2i
Arm Type
Active Comparator
Arm Description
Participants will be asked to take an SGLT2i for 6 months. 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 asked to take an SGLT2i. 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
empagliflozin (10 mg daily) or dapagliflozin (10 mg daily), depending on formulary coverage
Intervention Type
Other
Intervention Name(s)
No SGLT2i
Intervention Description
No SGLT2i
Primary Outcome Measure Information:
Title
Change in number of ramp stages needed to achieve hemodynamic optimization
Description
Measured by echocardiography
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
LVAD implantation
Have not already been prescribed management with an SGLT2i
Estimated glomerular filtration rate (eGFR) ≥ 30 milliliters(ml)/minute(min)/1.73 meter(m)2
Age ≥ 18 years-old
Able to provide informed consent
Exclusion Criteria:
Diagnosis of Type 1 diabetes mellitus
eGFR < 30 ml/min/1.73 m2
Age < 18 years-old
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Belkin, MD
Phone
773-702-9500
Email
Mark.Belkin@bsd.uchicago.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Belkin, 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@bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Mark Belkin, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
HF Patients With LVADs Being Treated With SGLT2i
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