NCT05278962

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2022

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 15, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

September 8, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

3 years

First QC Date

March 4, 2022

Last Update Submit

September 5, 2025

Conditions

Heart Failure With Reduced Ejection Fraction

Keywords

left ventricular assist deviceSGLT2i

Outcome Measures

Primary Outcomes (1)

  • Change in number of ramp stages needed to achieve hemodynamic optimization

    Measured by echocardiography

    6 months

Study Arms (2)

SGLT2i

ACTIVE COMPARATOR

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.

Drug: SGLT2i

No SGLT2i

ACTIVE COMPARATOR

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.

Other: No SGLT2i

Interventions

SGLT2iDRUG

empagliflozin (10 mg daily) or dapagliflozin (10 mg daily), depending on formulary coverage

SGLT2i
No SGLT2iOTHER

No SGLT2i

No SGLT2i

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Study Officials

  • Mark Belkin, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

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

September 9, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)