None listed
Conditions
Brief summary
Heart failure occurs when the heart muscle becomes too weak to pump blood to vital organs in the body. Common causes include prior heart attacks, cardiomyopathy (genetic or acquired), high blood pressure and diabetes. The long-term prognosis of heart failure is poor and multiple medications are required to treat it. Cardiac transplantation is a lifesaving procedure that can prolong the life of a person with heart failure. It requires lifelong immunosuppression to prevent rejection of the transplanted heart. Heart transplant survival rates have improved with modern immunosuppression medications. However, these medications can cause complications that eventuate in transplant-related illness and death. Prevention of medication-related complications, including diabetes, kidney impairment, and stiffening of the transplanted heart will improve health outcomes and financial costs associated with managing these complications. Excitingly, a new class of diabetes medications, the sodium glucose cotransporter-2 (SGLT2) inhibitors, have recently been shown, in large numbers of human subjects, to have major benefits for the heart. Not only do they reduce the risk of death from heart disease in people with type 2 diabetes, but they also improve heart function and reduce the likelihood of admission to hospital for heart failure. Interestingly, they also appear to exert this benefit in people without diabetes. In light of this evidence, it is possible that the SGLT2 inhibitors could improve the functionality of transplanted hearts. We will undertake a 12-month study of SGLT2 inhibitors in 100 patients who have undergone a heart transplant, to determine whether diabetes and other complications of immunosuppression medications can be prevented, and whether the efficacy of the transplanted heart, and the lives of the recipients, can be improved.
Interventions
Empagliflozin orally 10mg daily for 46 weeks. Empagliflozin film coated tablet encapsulated inside a hard gelatin capsule to match placebo.
Strategies to monitor adherence include a study medication diary, and return of the drug bottle.
Sponsors
Garvan Institute of Medical Research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed