Noninvasive Methods to Monitor Graft Survival in Heart Transplant Patients
NCT ID: NCT00466804
Last Updated: 2016-01-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
263 participants
OBSERVATIONAL
2007-06-30
2011-07-31
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Heart Transplant Recipients
People who will have a heart transplant
Heart transplant
People in this study will have a heart transplant and be monitored for signs of rejection
Interventions
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Heart transplant
People in this study will have a heart transplant and be monitored for signs of rejection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
10 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Clinical Trials in Organ Transplantation
NETWORK
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Peter S. Heeger, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Mohamed H. Sayegh, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Randall Starling, MD
Role: STUDY_CHAIR
The Cleveland Clinic
Locations
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University of California
San Francisco, California, United States
Northwestern University Medical School
Chicago, Illinois, United States
Loyola University School of Medicine
Maywood, Illinois, United States
University of Maryland
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Medical Center
Newark, New Jersey, United States
Mount Sinai School of Medicine
New York, New York, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Medical City Dallas Hospital
Dallas, Texas, United States
University of Utah, LDS Hospital
Salt Lake City, Utah, United States
University of Utah, VACM.LDS
Salt Lake City, Utah, United States
Countries
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References
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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.
Starling 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.
Zheng 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.
Starling 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.
Related Links
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Click here for the Clinical Trials in Organ Transplantation \[CTOT\] public Web site
National Institute of Allergy and Infectious Diseases (NIAID)
Other Identifiers
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DAIT CTOT-05
Identifier Type: -
Identifier Source: org_study_id
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