Clinical Trials in Organ Transplantation (CTOT) Protocol CTOT-05. Observational Study of Alloimmunity in Cardiac Transplant Recipients
Study Description
This trial is a non-randomized, prospective, multi-center, observational cohort clinical trial in cardiac transplant recipients. There is NO use of devices or drugs.
Following transplant, patients need to take a combination of drugs to prevent rejection of their new heart. Cardiac rejection has been studied for years but there is still incomplete knowledge as to the precise nature of the process and how this process can be predicted and prevented. It is important to understand “chronic rejection” in heart transplantation because it is a long-term complication that remains the major cause of death in patients more than one year post-transplantation.
Currently, non-invasive tests to detect or predict chronic rejection are not available. By comparing tests that use only blood or urine with the results of the heart biopsies, we hope to be able to determine if non-invasive tests can be reliable indicators of events occurring inside the heart. The purpose of this study is to determine whether tests performed on blood, urine, and heart biopsy tissue can predict rejection. If successful, this approach could allow us to adjust the treatment in individual patients with the use of these tests and decrease the need for heart biopsies and possibly extend the life of transplant recipients.
Contact Information
Status:
Name, Phone, Email:
Renee Neuharth, BS
801-587-4877
Renee.Neuharth@hsc.utah.edu
Principle Investigator:
Josef Stehlik, MD
Please Note:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician, we can help you find a University of Utah doctor or clinic location to meet your health care needs.
Although the studies described on this Web site may have potential benefits as described, the University of Utah and its physicians and affiliated hospitals cannot and do not guarantee or promise that you will receive any benefits from participating in a study.
Participant Eligibility
Inclusion Criteria:[NOTE TO PATIENTS: You may want to copy the following information and present it to your Doctor to determine your eligibility to participate in this study]
Patients who meet all of the following criteria are eligible for enrollment as study participants:
- Patients age > 18 years AND > 30kg.
- Individuals on the waiting list for a heart transplant for whom a donor heart has become available.
- Subject and/or parent guardian must be able to understand and provide informed consent.
**All cardiac transplants for patients under the age of 18 are performed at Primary Childrens' Hospital. The UofU and the VAMC will only be consenting patients over the age of 18.
Patients who meet any of these criteria are not eligible for enrollment as study participants:
- Women of childbearing potential with a positive serum or urine pregnancy test or nursing mothers. Women of childbearing potential not using 2 reliable forms of contraception, including a barrier method, for the duration of the study.
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
- Recipients of multiple organ transplants.
- Previous history of organ transplantation (other than heart transplantation).
- Patients who require revascularization prior to study entry (bypass, stenting, angioplasty)
- Patients with:
• Ejection fraction of <40%
• Ejection fraction of 20% decrease from baseline, and the need for inotropic agents
• Fractional shortening <20% or a 25% decrease from baseline, and the need for inotropic agents
• Need for inotropic agents due to a Cardiac Index of <2.0L/min/m2 or a 25% decrease from baseline. - Other co-morbidities determined by the site investigator that would preclude satisfactory completion of the study.
- Currently taking immunosuppression for non-transplant reasons (i.e., autoimmune disorders).
- Participation in an interventional clinical trial.
