Noninvasive Methods to Monitor Graft Survival in Heart Transplant Patients
Observational Study of Alloimmunity in Cardiac Transplant Recipients
1 other identifier
observational
263
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2007
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2007
CompletedFirst Posted
Study publicly available on registry
April 27, 2007
CompletedStudy Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedJanuary 1, 2016
December 1, 2015
4.1 years
April 25, 2007
December 31, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
12 months after enrollment in study
Study Arms (1)
Heart Transplant Recipients
People who will have a heart transplant
Interventions
People in this study will have a heart transplant and be monitored for signs of rejection
Eligibility Criteria
People who are on the waiting list for a heart transplant at one of the participating study sites (listed below)
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
University of California
San Francisco, California, 94143, United States
Northwestern University Medical School
Chicago, Illinois, 60611, United States
Loyola University School of Medicine
Maywood, Illinois, 60153, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Beth Israel Medical Center
Newark, New Jersey, 07112, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44122, United States
Medical City Dallas Hospital
Dallas, Texas, 75230, United States
University of Utah, LDS Hospital
Salt Lake City, Utah, 84148, United States
University of Utah, VACM.LDS
Salt Lake City, Utah, 84148, United States
Related Publications (4)
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.
PMID: 17168794BACKGROUNDStarling 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.
PMID: 17178330BACKGROUNDZheng 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.
PMID: 14563315BACKGROUNDStarling 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.
PMID: 26260101RESULT
Related Links
Biospecimen
Blood samples may be retained
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2007
First Posted
April 27, 2007
Study Start
June 1, 2007
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
January 1, 2016
Record last verified: 2015-12