Empagliflozin for Heart Transplant Recipients
Randomized Trial of SGLT2i in Heart Transplant Recipients
Recruiting
Phase 4
Interventional Study
Heart Transplant
Cardiovascular Disease
Kidney Disease
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 200 (estimated)
- Sponsor
- VA Office of Research and Development · Federal
Who this trial is looking for
This trial is looking for heart transplant recipients who are at least 3 months post-surgery. Participants will take either empagliflozin or a placebo daily for 12 months to see how it affects their kidney function and overall health.
Are You a Good Fit for This Trial?
You may be able to join if
- I am 18 years or older
- I am a heart transplant recipient and at least 3 months post-transplant
You may not be able to join if
- I have a kidney function level (eGFR) less than 20
- I have type 1 diabetes
- My blood sugar level (HbA1C) is over 10%
- I have low levels of protein in urine without type 2 diabetes
- I have an allergy or intolerance to SGLT2 inhibitors
- I have an active uncontrolled infection
- I have received a multi-organ transplant
- I have taken SGLT2 inhibitors in the last 30 days
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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 so…
Trial Locations
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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 un…
Contacts