Randomized Trial of Sodium-glucose Cotransporter 2 Inhibition in Heart Transplant Recipients

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Heart transplant (HTx) is an established therapy for advanced heart disease that restores quality of life and improves survival. However, due to preexisting comorbidities combined with the immunosuppressive therapies required after transplantation, HTx recipients remain at high risk for kidney, cardiovascular (CV), and metabolic disease. Large randomized clinical trials have recently shown that sodium-glucose cotransporter 2 inhibitors (SGLT2i) have potent kidney protective and CV benefits in many populations of patients with chronic kidney disease (CKD), CV disease and/or diabetes. SGLT2i have not been studied prospectively in HTx recipients, which represents a barrier to their use in this population. In this multicenter randomized controlled trial in Veterans with HTx, investigators will evaluate the potential benefits of empagliflozin on kidney function, cardiometabolic risk, erythropoiesis, and functional status. A total of 200 Veterans will be randomly assigned to receive either empagliflozin 10 mg daily or a matching placebo for 12 months.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age 18 years or older

• Heart transplant recipient, 3 months after transplant

Locations
United States
California
VA Palo Alto Health Care System, Palo Alto, CA
NOT_YET_RECRUITING
Palo Alto
Tennessee
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
NOT_YET_RECRUITING
Nashville
Texas
Michael E. DeBakey VA Medical Center, Houston, TX
NOT_YET_RECRUITING
Houston
Utah
VA Salt Lake City Health Care System, Salt Lake City, UT
RECRUITING
Salt Lake City
Virginia
Hunter Holmes McGuire VA Medical Center, Richmond, VA
NOT_YET_RECRUITING
Richmond
Wisconsin
William S. Middleton Memorial Veterans Hospital, Madison, WI
NOT_YET_RECRUITING
Madison
Contact Information
Primary
Heather Hanson, AAS BS
Heather.Hanson@va.gov
(801) 582-1565
Backup
Josef Stehlik, MD MPH
josef.stehlik@va.gov
(801) 582-1565
Time Frame
Start Date: 2026-01-20
Estimated Completion Date: 2030-02-28
Participants
Target number of participants: 200
Treatments
Experimental: Empagliflozin
A starting dose of empagliflozin 10 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Participating subjects will remain at this dose for the whole study duration of 12 months.
Placebo_comparator: Placebo
A starting dose of empagliflozin 10 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Participating subjects will remain at this dose for the whole study duration of 12 months.
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov