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Noninvasive Methods to Monitor Graft Survival in Heart Transplant Patients
This study is currently recruiting participants.
Verified by National Institute of Allergy and Infectious Diseases (NIAID), March 2007
Sponsors and Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00466804
  Purpose

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.


Condition Intervention
Cardiac Transplant
Procedure: Heart transplant

MedlinePlus related topics: Heart Transplantation
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: Observational Study of Alloimmunity in Cardiac Transplant Recipients

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Blood samples may be retained


Estimated Enrollment: 175
Study Start Date: June 2007
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
People who will have a heart transplant
Procedure: Heart transplant
People in this study will have a heart transplant and be monitored for signs of rejection

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.

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

People who are on the waiting list for a heart transplant at one of the participating study sites (listed below)

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00466804

Contacts
Contact: Yvonne Morrison, MS 301-451-3139 ymorrison@niaid.nih.gov

Locations
United States, California
University of California Recruiting
San Francisco, California, United States, 94143
Contact: Celia Rifkin     415-353-4146     rifkinc@surgery.ucsf.edu    
Principal Investigator: Teresa DeMarco, MD            
University of California Recruiting
Los Angeles, California, United States, 90095
Contact: Julie Chait     310-206-2906     jchait@mednet.ucla.edu    
Principal Investigator: Jon Kobashigawa, MD            
United States, Illinois
Northwestern University Medical School Recruiting
Chicago, Illinois, United States, 60611
Contact: Marci Worley, RN     312-695-0045     mworley@nmh.org    
Principal Investigator: William Cotts, MD            
Loyola University School of Medicine Recruiting
Maywood, Illinois, United States, 60153
Contact: Carol Kartje         ckartje@lumc.edu    
Principal Investigator: Alain Heroux, MD            
United States, Maryland
University of Maryland Not yet recruiting
Baltimore, Maryland, United States, 21201
Contact: Linda Romar         lromar@smail.umaryland.edu    
Principal Investigator: Richard N Pierson, III, M.D.            
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Suzanne Kelly, RN     617-525-7064     smkelley@partmenrs.org    
Principal Investigator: Michael Givertz, MD            
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Sandy Debronkart, RN     617-726-2631     sdebronkart@partners.org    
Principal Investigator: Joren Madesen, MD            
United States, New Jersey
Beth Israel Medical Center Recruiting
Newark, New Jersey, United States, 07112
Contact: Candace Carr, R.N.         Ccarr@sbhes.com    
Principal Investigator: David A Baran, M.D.            
United States, New York
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Contact: Hurdley Freemantle     212-659-8041     hurdley.freemantle@mountsinai.org    
Principal Investigator: Sean Pinney, MD            
United States, Ohio
The Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44122
Contact: Barbara Gus, RN     216-445-6552     gusb@ccf.org    
Principal Investigator: Randal Starling, MD            
United States, Texas
Medical City Dallas Hospital Recruiting
Dallas, Texas, United States, 75230
Contact: Tina Worley, R.N.     972-566-4083     tworley@crsti.org    
Principal Investigator: Judson Hunt, MD            
United States, Utah
University of Utah, VACM.LDS Recruiting
Salt Lake City, Utah, United States, 84148
Contact: Renee Neuharth, RN     801-581-4877     renee.neuharth@hsc.utah.edu    
Principal Investigator: Josef Stehlick, MD            
University of Utah, LDS Hospital Recruiting
Salt Lake City, Utah, United States, 84148
Contact: Kim Brunisholz     801-507-4777     Kim.Brunisholz@imail.org    
Principal Investigator: A.G. Kfoury, MD            
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Contact: Talley Mitchell     608-263-1739     tmmitchell@clinicaltrials.wisc.edu    
Principal Investigator: Maryl Johnson, MD            
Sponsors and Collaborators
Investigators
Principal Investigator: Peter S. Heeger, MD Mount Sinai School of Medicine
Principal Investigator: Mohamed H. Sayegh, MD Brigham and Women's Hospital
Study Chair: Kathryn Tinckam, MD Toronto General Hospital
Study Chair: Randall Starling, MD The Cleveland Clinic
  More Information

Click here for the Clinical Trials in Organ Transplantation [CTOT] public Web site  This link exits the ClinicalTrials.gov site

Publications:
Responsible Party: DAIT/NIAID ( Associat Director, Clinical Research Program )
Study ID Numbers: DAIT CTOT-05
Study First Received: April 25, 2007
Last Updated: October 6, 2008
ClinicalTrials.gov Identifier: NCT00466804  
Health Authority: United States: Institutional Review Board;   United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Transplant rejection
Organ Transplantation

ClinicalTrials.gov processed this record on January 15, 2009