HF Patients With LVADs Being Treated With SGLT2i
Heart Failure Patients With Left Ventricular Assist Devices Being Treated With Sodium-Glucose Co-Transporter 2 Inhibitors
1 other identifier
interventional
32
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Sep 2022
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2022
CompletedFirst Posted
Study publicly available on registry
March 15, 2022
CompletedStudy Start
First participant enrolled
September 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2025
CompletedResults Posted
Study results publicly available
May 8, 2026
CompletedJune 3, 2026
April 1, 2026
3 years
March 4, 2022
April 16, 2026
May 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Left Ventricular End-diastolic Dimension (LVEDD)
6 months after pre-LVAD
Secondary Outcomes (9)
Weight Change
6 months after pre-LVAD
Diuretic Dose
6 months after pre-LVAD
LVEF (Left Ventricular Ejection Fraction)
6 months after pre-LVAD
RV (Normal Right Ventricular) Size
6 months after pre-LVAD
Creatitine
6 months after pre-LVAD
- +4 more secondary outcomes
Study Arms (2)
SGLT2i
ACTIVE COMPARATORParticipants 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.
No SGLT2i
ACTIVE COMPARATORParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Diagnosis of Type 1 diabetes mellitus
- eGFR \< 30 ml/min/1.73 m2
- Age \< 18 years-old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Chicago
Chicago, Illinois, 60637, United States
Results Point of Contact
- Title
- Dr. Mark Belkin
- Organization
- University of Chicago
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Belkin, MD
University of Chicago
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2022
First Posted
March 15, 2022
Study Start
September 8, 2022
Primary Completion
August 31, 2025
Study Completion
August 31, 2025
Last Updated
June 3, 2026
Results First Posted
May 8, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share