SGLT2 Inhibition with Empagliflozin on Metabolic, Cardiac and Renal Outcomes in Recent Cardiac Transplant Recipients

Phase 2

Recruiting

• Conditions: Cardiac transplant; Diabetes; Renal disease; Cardiovascular - Other cardiovascular diseases; Metabolic and Endocrine - Diabetes; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12622000978763
• Lead Sponsor: Garvan Institute of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-11
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified