Noninvasive Methods to Monitor Graft Survival in Heart Transplant Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Transplant

Age range

10 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, San Francisco, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heart transplant

Procedure

People in this study will have a heart transplant and be monitored for signs of rejection

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Collaborators

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

Registry information

Official study title

Observational Study of Alloimmunity in Cardiac Transplant Recipients

Important dates

Study start: 2007
Primary completion: 2011
Study completion: 2011
First posted: Apr 27, 2007
Registry last updated: Jan 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed