Safety Outcomes of Lower Immunosuppression Versus Traditional Immunosuppression in Heart Transplant Recipients (TICTAC)

Newark Beth Israel Medical Center

Status and phase: Completed; Phase 4

Conditions: Immunosuppression

Treatments: Drug: combination therapy; Drug: Tacrolimus

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00299221

TICTAC

Details and patient eligibility

About

This was a study to compare less intense immunosuppression with a more traditional approach. The hypothesis was that less immunosuppression will provide similar protection against rejection than typical 2-3 drug therapy.

Full description

This was a prospective, randomized, controlled (open-label) trial of 2 different strategies of immunosuppression in de novo post-heart transplant patients. The hypothesis was that immunosuppression with tacrolimus and mycophenolate mofetil, coupled with rapid steroid weaning would provide similar anti-rejection efficacy as tacrolimus with only a 2 week course of mycophenolate mofetil but including the same rapid steroid wean.

The primary endpoint was the mean International Society for Heart and Lung Transplantation (ISHLT) biopsy score over the first 6 months post-transplant. Secondary endpoints included the incidence of adverse events over the first year post-transplant, as well as all-cause mortality, 12 month ISHLT biopsy score (mean), along with the incidence of proven cytomegalovirus disease. In addition, the incidence of allograft vasculopathy as assessed by angiography or intravascular ultrasound was compared between groups.

Enrollment: 150 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult (at least 18 years old)
• Undergoing a first heart transplant (no heart/kidney transplants), who receive their transplant at one of the study sites
• Specifically INCLUDED are patients on ventricular assist devices, and allosensitized recipients

Exclusion criteria

• Age less than 18
• Inability to provide proper informed consent
• Combined organ transplantation
• Re-Transplantation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Monotherapy

Active Comparator group

Description:

Tacrolimus alone

Treatment:

Drug: Tacrolimus

Combination therapy

Active Comparator group

Description:

tacrolimus with mycophenolate mofetil

Treatment:

Drug: Tacrolimus

Drug: combination therapy