Safety Outcomes of Lower Immunosuppression Versus Traditional Immunosuppression in Heart Transplant Recipients

Phase 4

Completed

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Combination therapy	Tacrolimus	tacrolimus with mycophenolate mofetil
Monotherapy	Tacrolimus	Tacrolimus alone
Combination therapy	combination therapy	tacrolimus with mycophenolate mofetil

Primary Outcome Measures

Name	Time	Method
Mean International Society for Heart and Lung Transplantation Biopsy Score Over the First 6 Months Post-transplantation	6 months	Mean ISHLT biopsy score Biopsies of the heart may be various grades and each is assigned a numerical score. Grade 0 is 0 points, 1A = 1, 1B = 2, grade 2 = 3, grade 3A = 4, Grade 3B = 5, and grade 4 = 6 units. The mean biopsy score is the numeric average of the biopsy scores for the first 6 post-transplant months. Best value is 0, worst score is 6.

Secondary Outcome Measures

Name	Time	Method
Percent of Patients Alive at One Year Post-transplant	1 year	Percent of patients alive at one year post-transplant. In other words, all cause mortality over time
Number of Patients With Cytomegalovirus (CMV) at One Year Post-transplant	1 year	Number of patients developing cytomegalovirus disease by 1 year post-transplant
Number of Patients With Allograft Vasculopathy (CAD) at One Year Post Transplant	1 year	Number of patients diagnosed with allograft vasculopathy / coronary artery disease (CAD) at one year post transplant
Mean ISHLT Biopsy Score Over First Year Post-transplant	1 year	Mean ISHLT biopsy score Biopsies of the heart may be various grades and each is assigned a numerical score. Grade 0 is 0 points, 1A = 1, 1B = 2, grade 2 = 3, grade 3A = 4, Grade 3B = 5, and grade 4 = 6 units. The mean biopsy score is the numeric average of the biopsy scores for the first 6 post-transplant months. Best value is 0, worst score is 6.

Locations (2): Mt. Sinai Cardiovascular Institute
🇺🇸
New York, New York, United States
Newark Beth Israel Medical Center
🇺🇸
Newark, New Jersey, United States