ACTRN12622000978763
Recruiting
Phase 2
SGLT2 Inhibition with Empagliflozin on Metabolic, Cardiac and Renal Outcomes in Recent Cardiac Transplant Recipients
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Cardiac transplant
- Sponsor
- Garvan Institute of Medical Research
- Enrollment
- 100
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Sex: men and women
- •Age range: over 18 years old
- •Cardiac transplant recipients recruited within 6\-8 weeks from the date of cardiac transplant
- •Free from major rejection at enrolment
- •Baseline eGFR \>30 mL/min/1\.73m2
- •Willingness to give written informed consent and willingness to participate to and comply with the study
Exclusion Criteria
- •Exposure to an SGLT2 inhibitor within the last 30 days
- •Previous adverse event related to SGLT2 inhibitor use
- •History of diabetic ketoacidosis
- •History of urosepsis
- •Fasting beta hydroxybutyrate \>1\.7 mmol/L at baseline
- •Known major organ dysfunction (eGFR \< 30 mL/min/1\.73m2, liver disease transaminases \> 5 times the upper limit of normal, current cancer or uncontrolled thyroid dysfunction). These conditions either interfere with the excretion or metabolism of the test medication, or would interfere with measurement of the study outcome.
- •Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study
Outcomes
Primary Outcomes
Not specified
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