Noninvasive Methods to Monitor Graft Survival in Heart Transplant Patients
- Conditions
- Heart Transplant
- Interventions
- Procedure: Heart transplant
- Registration Number
- NCT00466804
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 263
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Heart Transplant Recipients Heart transplant People who will have a heart transplant
- Primary Outcome Measures
Name Time Method Composite Measure of Transplant Health 12 months after enrollment in study A composite of incidence of the following:
* Death,
* Re-transplantation or re-listed for transplantation,
* Biopsy proven acute rejection (BPAR) of \> 2R,
* Episode of rejection associated with hemodynamic compromise,
* Coronary artery vasculopathy defined by a change in MIT of \>0.5 mm between study entry and 12 months.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
University of Maryland
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
University of California
🇺🇸San Francisco, California, United States
University of Utah, LDS Hospital
🇺🇸Salt Lake City, Utah, United States
University of Utah, VACM.LDS
🇺🇸Salt Lake City, Utah, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
Northwestern University Medical School
🇺🇸Chicago, Illinois, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
Loyola University School of Medicine
🇺🇸Maywood, Illinois, United States