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

Completed · Phase 4

Conditions studied: Immunosuppression

In brief

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.

Key facts

Study ID

NCT00299221

Run by

Newark Beth Israel Medical Center

People needed

150

Starts

2004-04-01

Expected to finish

2009-12-01

Last updated by the study team

2015-05-28

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Newark Beth Israel Medical Center — Newark, New Jersey, United States
• Mt. Sinai Cardiovascular Institute — New York, New York, United States

Full record on ClinicalTrials.gov

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