Randomized Trial of SGLT2i in Heart Transplant Recipients

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Sep 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called empagliflozin in veterans who have received a heart transplant. Heart transplant patients often face challenges with their kidney health and heart function, but recent research suggests that empagliflozin may help improve these issues. The trial will involve 200 participants who will be randomly assigned to take either empagliflozin or a placebo (a pill that looks the same but has no active medication) for 12 months. The goal is to see if empagliflozin can help protect kidney function, reduce heart disease risk, improve blood health, and enhance overall well-being.

To be eligible for this trial, participants must be at least 18 years old and have had a heart transplant at least three months prior. However, some individuals may not qualify, including those with very low kidney function or certain health conditions like type 1 diabetes. Participants will be monitored throughout the year to assess the medication's effects and ensure their safety. This study is an important step in understanding how empagliflozin can be used to support heart transplant recipients in managing their health better.

Gender

ALL

Eligibility criteria

• 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