Empagliflozin to protect kidney and heart health after heart transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, placebo-controlled, multicenter Phase 4 trial will enroll 200 Veterans at least 3 months after heart transplant and assign them to empagliflozin or matching placebo. Participants will be followed with regular clinic visits and laboratory testing to track kidney function, cardiometabolic measures, markers of erythropoiesis, and functional status. Key exclusions include severe kidney dysfunction (eGFR <20 mL/min/1.73 m2), type 1 diabetes, very high HbA1c (>10%), recent SGLT2i use, multiorgan transplant, active uncontrolled infection, and pregnancy or breastfeeding without contraception. The aim is to see if empagliflozin can slow kidney decline, reduce cardiovascular complications, and improve metabolic and functional outcomes after heart transplant.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18 years or older
2. Heart transplant recipient, 3 months after transplant

Exclusion Criteria:

1. eGFR \<20 mL/min/1.73m2
2. Type 1 diabetes mellitus
3. HbA1C \>10%
4. Baseline UACR \<30 mg/g in patients without T2D
5. Known allergy or intolerance to SGLT2i
6. Active uncontrolled infection
7. Multiorgan transplant
8. SGLT2i treatment in the last 30 days
9. Pregnancy, breast-feeding or woman of child-bearing age not on birth control

Where it's running

• VA Salt Lake City Health Care System, Salt Lake City, UT
  Salt Lake City, Utah, United States Recruiting
• VA Palo Alto Health Care System, Palo Alto, CA
  Palo Alto, California, United States Not yet recruiting
• Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
  Nashville, Tennessee, United States Not yet recruiting
• Michael E. DeBakey VA Medical Center, Houston, TX
  Houston, Texas, United States Not yet recruiting
• Hunter Holmes McGuire VA Medical Center, Richmond, VA
  Richmond, Virginia, United States Not yet recruiting
• William S. Middleton Memorial Veterans Hospital, Madison, WI
  Madison, Wisconsin, United States Not yet recruiting

Study contacts

• Principal investigator: Josef Stehlik, MD MPH — VA Salt Lake City Health Care System, Salt Lake City, UT
• Study coordinator: Heather Hanson, AAS BS
• Email: Heather.Hanson@va.gov
• Phone: (801) 582-1565

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.