Noninvasive Methods to Monitor Graft Survival in Heart Transplant Patients

December 31, 2015 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

263

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Medical School
      • Maywood, Illinois, United States, 60153
        • Loyola University School of Medicine
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • New Jersey
      • Newark, New Jersey, United States, 07112
        • Beth Israel Medical Center
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • The Cleveland Clinic Foundation
    • Texas
      • Dallas, Texas, United States, 75230
        • Medical City Dallas Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84148
        • University of Utah, LDS Hospital
      • Salt Lake City, Utah, United States, 84148
        • University of Utah, VACM.LDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months after enrollment in study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
Clinical Trials in Organ Transplantation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

April 25, 2007

First Submitted That Met QC Criteria

April 25, 2007

First Posted (Estimate)

April 27, 2007

Study Record Updates

Last Update Posted (Estimate)

January 1, 2016

Last Update Submitted That Met QC Criteria

December 31, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DAIT CTOT-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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