Noninvasive Methods to Monitor Graft Survival in Heart Transplant Patients
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00466804 |
Recruitment Status :
Completed
First Posted : April 27, 2007
Last Update Posted : January 1, 2016
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Condition or disease | Intervention/treatment |
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Heart Transplant | Procedure: Heart transplant |
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.
Study Type : | Observational |
Actual Enrollment : | 263 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | Observational Study of Alloimmunity in Cardiac Transplant Recipients |
Study Start Date : | June 2007 |
Actual Primary Completion Date : | July 2011 |
Actual Study Completion Date : | July 2011 |

Group/Cohort | Intervention/treatment |
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Heart Transplant Recipients
People who will have a heart transplant
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Procedure: Heart transplant
People in this study will have a heart transplant and be monitored for signs of rejection |
- Composite Measure of Transplant Health [ Time Frame: 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.
Biospecimen Retention: Samples With DNA

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 10 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00466804
United States, California | |
University of California | |
San Francisco, California, United States, 94143 | |
United States, Illinois | |
Northwestern University Medical School | |
Chicago, Illinois, United States, 60611 | |
Loyola University School of Medicine | |
Maywood, Illinois, United States, 60153 | |
United States, Maryland | |
University of Maryland | |
Baltimore, Maryland, United States, 21201 | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02115 | |
United States, New Jersey | |
Beth Israel Medical Center | |
Newark, New Jersey, United States, 07112 | |
United States, New York | |
Mount Sinai School of Medicine | |
New York, New York, United States, 10029 | |
United States, Ohio | |
The Cleveland Clinic Foundation | |
Cleveland, Ohio, United States, 44122 | |
United States, Texas | |
Medical City Dallas Hospital | |
Dallas, Texas, United States, 75230 | |
United States, Utah | |
University of Utah, LDS Hospital | |
Salt Lake City, Utah, United States, 84148 | |
University of Utah, VACM.LDS | |
Salt Lake City, Utah, United States, 84148 |
Principal Investigator: | Peter S. Heeger, MD | Icahn School of Medicine at Mount Sinai | |
Principal Investigator: | Mohamed H. Sayegh, MD | Brigham and Women's Hospital | |
Study Chair: | Randall Starling, MD | The Cleveland Clinic |
Publications of Results:
Other Publications:
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00466804 |
Other Study ID Numbers: |
DAIT CTOT-05 |
First Posted: | April 27, 2007 Key Record Dates |
Last Update Posted: | January 1, 2016 |
Last Verified: | December 2015 |
heart transplant recipients organ transplantation immune biomarkers transplant rejection |