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Noninvasive Methods to Monitor Graft Survival in Heart Transplant Patients

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
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Clinical Trials in Organ Transplantation
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Description
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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.

Condition or disease Intervention/treatment
Heart Transplant Procedure: Heart transplant

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
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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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Heart Transplant Recipients
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


Outcome Measures
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Primary Outcome Measures :
  1. 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
Blood samples may be retained

Eligibility Criteria
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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
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
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
National Heart, Lung, and Blood Institute (NHLBI)
Clinical Trials in Organ Transplantation
Investigators
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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
More Information
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Additional Information:

Publications of Results:

Other Publications:

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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
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
heart transplant recipients
organ transplantation
immune biomarkers
transplant rejection