Research Study for Heart Transplant Patients

Study Summary

The University of Chicago and Dr. Allen Anderson are conducting a research study to compare the safety and effectiveness of monitoring acute rejection using endomyocardial (heart) biopsies to that of a blood test. We hope to learn if acute rejection of the transplanted heart can be safely monitored using a newly developed blood test instead of using repeated heart biopsies. This blood test identifies the expression of genes in blood cells that circulate in the blood and are associated with rejection. Genes are the material passed from parent to child which determine the make-up of the body and mind. The study will be conducted in heart transplant recipients who are more than one year out from their transplant because the probability of acute rejection is much lower after the first year. Half of the subjects who agree to participate in this study will be randomly assigned (like the flip of a coin) to monitoring of their blood and will only have a heart biopsy if the blood test suggests that acute rejection may be occurring or if there is any evidence of heart dysfunction. The remainder of the subjects will have conventional monitoring of acute rejection, which involves obtaining heart biopsies at three to 12 month intervals.

Subjects one year post transplant will be seen by their doctor at three months, six months, and 12 months. Subjects two years post transplant and greater will be seen every 12 months. At the clinic visit you will undergo a physical examination by your doctor to detect any symptoms of heart dysfunction. You will undergo echocardiography (ultrasound of the heart). You will have about three teaspoons of blood drawn as part of your normal routine care. An additional four teaspoons will be drawn for the study blood test that determines whether your heart transplant is being rejected. If you are assigned to the biopsy group, you will also have your routine heart biopsy done as part of these visits. Lastly, you will be asked to complete a quality of life and health questionnaire at the beginning of the study and after one year and two years.

Benefits

We cannot and do not guarantee or promise that you will receive any benefits from this study.

However, if you are assigned to the blood test group, you may have fewer biopsies than are normally performed in the care of heart transplant recipients. This will translate to a lower risk of biopsy complications such as heart perforation, damage to one of the heart valves, and bleeding.

In addition, your participation may contribute to the advancement of medical knowledge about factors related to the development of heart transplant rejection.

Participation Details

Initial selection criteria include:

• Must be at least 18 years of age
• Must not be pregnant during the study
• Must be a heart transplant recipient who is in the second to fifth year post-transplant
• Must meet study medical criteria as evaluated by Dr. Anderson
• Must be available for clinic visits for the duration of the study

Study Director: Dr. Allen Anderson
Department: Cardiology

For more information contact:
lbond@medicine.bsd.uchicago.edu
(773) 702-6385

IRB: #15093A