Heart TransplantNCT00466804
Noninvasive Methods to Monitor Graft Survival in Heart Transplant Patients
An observational study of Heart Transplant, run by National Institute of Allergy and Infectious Diseases (NIAID) at 12 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Heart Transplant
- What is being tested?
- Heart transplant
- Type of treatment
- Surgery or procedure
- How many people
- 263 participants
- Where
- 12 sitesUnited States
- Study dates
- Jun 2007to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: People who are on the waiting list for a heart transplant at one of the participating study sites (listed below)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University of Maryland
Baltimore, Maryland, 21201
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Northwestern University Medical School
Chicago, Illinois, 60611
The Cleveland Clinic Foundation
Cleveland, Ohio, 44122
Medical City Dallas Hospital
Dallas, Texas, 75230
Loyola University School of Medicine
Maywood, Illinois, 60153
Mount Sinai School of Medicine
New York, New York, 10029
Beth Israel Medical Center
Newark, New Jersey, 07112
University of Utah, LDS Hospital
Salt Lake City, Utah, 84148
University of Utah, VACM.LDS
Salt Lake City, Utah, 84148
University of California
San Francisco, California, 94143
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Transplant
- Being tested
- Heart transplant
- Keywords
- heart transplant recipients, organ transplantation, immune biomarkers, transplant rejection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart transplantProcedure or surgery
People in this study will have a heart transplant and be monitored for signs of rejection
| Study group | Role | What they receive |
|---|---|---|
| Heart Transplant Recipients | People who will have a heart transplant Receives: Procedure: Heart transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Measure of Transplant Health
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.
Measured: 12 months after enrollment in study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study startJun 2007
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart TransplantStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Clinical Trials in Organ Transplantation
- Responsible party
- Sponsor
- Investigators
- Peter S. Heeger, MD, Principal investigator, Icahn School of Medicine at Mount SinaiMohamed H. Sayegh, MD, Principal investigator, Brigham and Women's HospitalRandall Starling, MD, Study chair, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00466804
- Sponsor's protocol ID
- DAIT CTOT-05
- Status last verified
- Sep 2026
- First submitted
- 25 Apr 2007
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jiang S, Lechler RI. CD4+CD25+ regulatory T-cell therapy for allergy, autoimmune disease and transplant rejection. Inflamm Allergy Drug Targets. 2006 Dec;5(4):239-42. doi: 10.2174/187152806779010981.
PubMed 17168794Starling RC, Pham M, Valantine H, Miller L, Eisen H, Rodriguez ER, Taylor DO, Yamani MH, Kobashigawa J, McCurry K, Marboe C, Mehra MR, Zuckerman A, Deng MC; Working Group on Molecular Testing in Cardiac Transplantation. Molecular testing in the management of cardiac transplant recipients: initial clinical experience. J Heart Lung Transplant. 2006 Dec;25(12):1389-95. doi: 10.1016/j.healun.2006.10.002. No abstract available.
PubMed 17178330Zheng XX, Sanchez-Fueyo A, Sho M, Domenig C, Sayegh MH, Strom TB. Favorably tipping the balance between cytopathic and regulatory T cells to create transplantation tolerance. Immunity. 2003 Oct;19(4):503-14. doi: 10.1016/s1074-7613(03)00259-0.
PubMed 14563315Starling RC, Stehlik J, Baran DA, Armstrong B, Stone JR, Ikle D, Morrison Y, Bridges ND, Putheti P, Strom TB, Bhasin M, Guleria I, Chandraker A, Sayegh M, Daly KP, Briscoe DM, Heeger PS; CTOT-05 consortium. Multicenter Analysis of Immune Biomarkers and Heart Transplant Outcomes: Results of the Clinical Trials in Organ Transplantation-05 Study. Am J Transplant. 2016 Jan;16(1):121-36. doi: 10.1111/ajt.13422. Epub 2015 Aug 10.
PubMed 26260101
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Alloimmunity in Cardiac Transplant Recipients
- ClinicalTrials.gov ID
- NCT00466804
- Acronym / sponsor ID
- DAIT CTOT-05
- Conditions
- Heart Transplant
- Keywords
- heart transplant recipients, organ transplantation, immune biomarkers, transplant rejection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Clinical Trials in Organ Transplantation
- Study start
- Jun 2007
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 27 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Transplant Recipients | – | Procedure: Heart transplantPeople who will have a heart transplant |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People who are on the waiting list for a heart transplant at one of the participating study sites (listed below)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart transplantPeople in this study will have a heart transplant and be monitored for signs of rejection | Procedure or surgery | Heart Transplant Recipients |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Background: PubMed 17168794Jiang S, Lechler RI. CD4+CD25+ regulatory T-cell therapy for allergy, autoimmune disease and transplant rejection. Inflamm Allergy Drug Targets. 2006 Dec;5(4):239-42. doi: 10.2174/187152806779010981.
- Background: PubMed 17178330Starling RC, Pham M, Valantine H, Miller L, Eisen H, Rodriguez ER, Taylor DO, Yamani MH, Kobashigawa J, McCurry K, Marboe C, Mehra MR, Zuckerman A, Deng MC; Working Group on Molecular Testing in Cardiac Transplantation. Molecular testing in the management of cardiac transplant recipients: initial clinical experience. J Heart Lung Transplant. 2006 Dec;25(12):1389-95. doi: 10.1016/j.healun.2006.10.002. No abstract available.
- Background: PubMed 14563315Zheng XX, Sanchez-Fueyo A, Sho M, Domenig C, Sayegh MH, Strom TB. Favorably tipping the balance between cytopathic and regulatory T cells to create transplantation tolerance. Immunity. 2003 Oct;19(4):503-14. doi: 10.1016/s1074-7613(03)00259-0.
- Results publication: PubMed 26260101Starling RC, Stehlik J, Baran DA, Armstrong B, Stone JR, Ikle D, Morrison Y, Bridges ND, Putheti P, Strom TB, Bhasin M, Guleria I, Chandraker A, Sayegh M, Daly KP, Briscoe DM, Heeger PS; CTOT-05 consortium. Multicenter Analysis of Immune Biomarkers and Heart Transplant Outcomes: Results of the Clinical Trials in Organ Transplantation-05 Study. Am J Transplant. 2016 Jan;16(1):121-36. doi: 10.1111/ajt.13422. Epub 2015 Aug 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter S. Heeger, MD principal investigator
Icahn School of Medicine at Mount Sinai
Mohamed H. Sayegh, MD principal investigator
Brigham and Women's Hospital
Randall Starling, MD study chair
The Cleveland Clinic
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Transplant, run by National Institute of Allergy and Infectious Diseases (NIAID) at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Measure of Transplant Health (time frame: 12 months after enrollment in study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00466804, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.