None listed
Conditions
Brief summary
The primary purpose of the study is to assess left ventricular hypertrophy prevention at 1 year after heart transplantation with everolimus in combination with low-dose calcineurin inhibitors compared to full-dose calcineurin inhibitors.
Interventions
RADTAC arm: Everolimus tablets, administered orally, twice daily in combination with low dose tacrolimus, mycophenolate +/- predinsolone, all taken orally, commenced at 3 months post transplantation and continued for at least 9 months. The Everolimus will be started at 0.5mg twice daily and then adjusted according to the plasma level aiming 3-8 mcg/lit. The tacrolimus dose will be started at 0.5mg twice daily and then adjusted according to the plasma levels aiming 2-5mcg/lit. The Mycophenolate d
RADTAC arm: Everolimus tablets, administered orally, twice daily in combination with low dose tacrolimus, mycophenolate +/- predinsolone, all taken orally, commenced at 3 months post transplantation and continued for at least 9 months. The Everolimus will be started at 0.5mg twice daily and then adjusted according to the plasma level aiming 3-8 mcg/lit. The tacrolimus dose will be started at 0.5mg twice daily and then adjusted according to the plasma levels aiming 2-5mcg/lit. The Mycophenolate dose will 1000-2000mg twice daily and prednisole maintenance dose will be 7.5-10mg daily as per current standard of care for heart transplantation. To improve the patient`s adherence to the treatment, they will be asked about the medications and doses they have been taking as well as encouraged to take medications at each clinical visit. Their adherence will be monitored by checking plasma drug levels at each clinical visit.
Sponsors
St. Vincent`s Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
Stable orthotopic heart transplant recipients at 3-months after heart transplantation and willingness to provide informed consent.
Exclusion criteria
Hemodynamic instability at 10 weeks after transplantation, greater than 2 x 3A rejection or single 3B rejection, ongoing sepsis at 10 weeks after transplantation, ongoing wound dehiscence or infection at 10 weeks after transplantation, end-stage renal failure requiring dialysis at 10 weeks after transplantation, and contraindication to cardiovascular magnetic resonance scanning
Outcome results
None listed