CompletedPhase 4

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

United States150 participantsStarted 2004-04

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Mean International Society for Heart and Lung Transplantation Biopsy Score Over the First 6 Months Post-transplantation

Timeframe: 6 months

Trial details

NCT IDNCT00299221

SponsorNewark Beth Israel Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-06

Results submitted2010-09-10

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