CompletedNot Applicable

Study of Heart Transplant Rejection

United States188 participantsStarted 2003-04-07

Plain-language summary

This study will investigate the causes of acute and chronic rejection of transplanted hearts. To find better ways to detect, treat and possibly prevent heart transplant rejection, more information about the cause is needed. Acute and chronic heart transplant rejection may be caused by certain substances the body produces in response to the new heart. This study will try to find a blood or urine test that detects genes and proteins that can serve as markers of rejection. Such a test may lead to earlier detection and improved treatment. Patients 18 years and above who are on a wait list for heart transplant at a UNOS-approved heart transplant center, whose institutional review board has approved this protocol, may be eligible for this study. Healthy volunteers will also be included in the study to establish a database of normal values for comparison with patients undergoing heart transplant. In addition, patients who have had a heart transplant within the past 1 to 5 years will be enrolled in a pilot study. Normal volunteers will be screened for participation with an electrocardiogram (EKG) and echocardiogram, non-invasive tests to evaluate heart function. Participants will undergo the following procedures: * Review of medical records Patients who have had a heart transplant and those on a wait list to receive a heart will have their medical records reviewed to collect information on their condition. * Blood samples 60 cc (about 3 tablespoons) of blood will be collected from all participants by needle stick in a vein. The sample will be analyzed for genes and proteins that might predict heart rejection. In addition, many genes in blood cells and cells lining blood vessels that are unrelated to heart transplant rejection and whose functions or significance are unknown will also be examined for ideas for future research. Patients enrolled while on a wait list will, after transplantation, have an additional 44 cc (about 2 tablespoons) of blood collected at each heart biopsy and rejection episode during the first year of transplant, and 60 cc collected with each yearly biopsy for the next 9 years. * Urine samples Between 100 and 300 cc (3 to 10 ounces) of urine may be collected from all participants to confirm blood test results

Who can participate

Age range18 Years – 100 Years

SexALL

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Inclusion criteria

✓. Adult heart transplant center generally accepts patients within the physiologic age range of 12 to 65 years old, however, for our study heart transplant patients must be 18 years of age or above.
✓. Indication for cardiac transplantation as outlined by the 24th Bethesda Conference on Cardiac Transplantation. These are as follows:

Exclusion criteria

✕. EKG with evidence of clinically relevant heart disease.
✕. Echocardiogram with evidence of clinically relevant heart disease.
✕. Any disease process that is not well controlled by medications.
✕. Total tobacco use for greater than one month over the last 5 years.
✕. Symptoms of coronary or cardiac insufficiency.
✕. More than one major risk factor for coronary artery disease excluding gender or age.
✕. Confirmed intrauterine pregnancy in women.

What they're measuring

Rejection warranting medical intervention

Timeframe: end of study

Pathologically determined tissue rejection grades irrespective of treatment.

Timeframe: end of study

Trial details

NCT IDNCT00042614

SponsorNational Institutes of Health Clinical Center (CC)

Sponsor typeNIH

Study typeOBSERVATIONAL

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