Noninvasive Methods to Monitor Graft Survival in Heart Transplant Patients
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 10 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2007 |
| End Date: | July 2011 |
Observational Study of Alloimmunity in Cardiac Transplant Recipients
Injury of transplant tissue by a transplant recipient's immune system continues to be the
leading cause of graft rejection and recipient death. The purpose of this study is to
identify a single test or a combination of noninvasive tests currently used for heart
transplant monitoring that correlate to long-term graft survival.
leading cause of graft rejection and recipient death. The purpose of this study is to
identify a single test or a combination of noninvasive tests currently used for heart
transplant monitoring that correlate to long-term graft survival.
A major cause of heart transplant failure is the blockage of blood flow from lesions caused
by ongoing injury and repair of the graft by the host's immune system. However, the role of
T cells, antibodies, and other parts of the recipient's immune system are not well
understood in transplant injury. Currently, there are no effective, noninvasive ways to
detect or predict how an individual's immune system will react to a transplant. The purpose
of this study is to correlate current noninvasive monitoring tests with long-term graft
survival and function, and determine which tests are the most accurate predictors of this
survival.
Participants in this study must currently be on the waiting list for a heart transplant and
have a donor heart available to them. This study will consist of six study visits over 12
months. The baseline visit will occur on the day of transplantation. Follow-up visits will
occur at Week 6 and Months 3, 6, 9, and 12 post-transplant. At each visit, a physical exam,
medication tracking, assessment of graft survival, and blood and urine collection will
occur. At the Week 6 and Month 12 visits, intravascular ultrasound and echocardiograms will
occur. At the Week 6, Month 6, and Month 12 visits, endomyocardial biopsies will also occur.
No immunosuppressive therapy will be provided by the study.
by ongoing injury and repair of the graft by the host's immune system. However, the role of
T cells, antibodies, and other parts of the recipient's immune system are not well
understood in transplant injury. Currently, there are no effective, noninvasive ways to
detect or predict how an individual's immune system will react to a transplant. The purpose
of this study is to correlate current noninvasive monitoring tests with long-term graft
survival and function, and determine which tests are the most accurate predictors of this
survival.
Participants in this study must currently be on the waiting list for a heart transplant and
have a donor heart available to them. This study will consist of six study visits over 12
months. The baseline visit will occur on the day of transplantation. Follow-up visits will
occur at Week 6 and Months 3, 6, 9, and 12 post-transplant. At each visit, a physical exam,
medication tracking, assessment of graft survival, and blood and urine collection will
occur. At the Week 6 and Month 12 visits, intravascular ultrasound and echocardiograms will
occur. At the Week 6, Month 6, and Month 12 visits, endomyocardial biopsies will also occur.
No immunosuppressive therapy will be provided by the study.
Inclusion Criteria:
- Age greater than 10 and a body mass of 30 kg (66 lbs) or more
- On waiting list for a heart transplant for whom a donor heart available
- Willing to comply with study protocol
- Willing to use acceptable forms of contraception
- Parent or guardian willing to provide consent, if applicable
Exclusion Criteria:
- Receiving multiple organ transplants
- Previously received organ transplants
- Other comorbidities that, in the opinion of the site investigator, would interfere
with the study
- Currently taking immunosuppression for nontransplant reasons
- Participation in an interventional clinical trial
- Pregnancy or breastfeeding
We found this trial at
12
sites
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Medical City Dallas Hospital If you have concerns for your health, that of a family...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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