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Protocol Details

Acute Cardiac Allograft Cellular Rejection and Cardiac Allograft Vasculopathy: Identification of Diagnostic Biomarkers and Target Pathways for Preventive Therapy

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18 Years
Max Age: 100 Years

Referral Letter Required


Population Exclusion(s)



Natural History

Recruitment Keyword(s)

Heart Transplant;
Healthy Volunteer;
Normal Control


Heart Transplantation

Investigational Drug(s)


Investigational Device(s)




Supporting Site

NIH Clinical Center

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

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INCLUSION CRITERIA - for Transplant Patients:

1. 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.

2. Indication for cardiac transplantation as outlined by the 24th Bethesda Conference on Cardiac Transplantation. These are as follows:

-Peak VO(2) less than 10 ml/kg per minute or less than 50% of maximal predicted VO(2) with achievement of anaerobic metabolism.

-Severe cardiac ischemia consistently limiting routine activity not amenable to surgical or percutaneous revascularization.

-Recurrent symptomatic ventricular arrhythmias refractory to all accepted therapeutic modalities.

EXCLUSION CRITERIA - for Transplant Patients:

Adult heart transplant centers exclude infants, toddlers, and children with a physiologic age less than 12, and adults with advanced physiologic age (less than 65), however, for our study we will exclude heart transplant patients less than 18 years of age.

The final decision to exclude a candidate from cardiac transplantation will be made by the hospital's heart transplant committee. The committee uses, as a guideline, the criteria outlined in the 24th Bethesda conference.

INCLUSION CRITERIA - for Control Subjects:

Any healthy normal man or women who is the appropriate age and gender for matching to a transplant patient.

EXCLUSION CRITERIA - For Control Subjects:

1. EKG with evidence of clinically relevant heart disease.

2. Echocardiogram with evidence of clinically relevant heart disease.

3. Any disease process that is not well controlled by medications.

4. Total tobacco use for greater than one month over the last 5 years.

5. Symptoms of coronary or cardiac insufficiency.

6. More than one major risk factor for coronary artery disease excluding gender or age.

7. Confirmed intrauterine pregnancy in women.

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Zavazava N, B(SqrRoot)(Delta)ttcher H, Ruchholtz WM. Soluble MHC class I antigens (sHLA) and anti-HLA antibodies in heart and kidney allograft recipients. Tissue Antigens. 1993 Jul;42(1):20-6.

Pelletier RP, Morgan CJ, Sedmak DD, Miyake K, Kincade PW, Ferguson RM, Orosz CG. Analysis of inflammatory endothelial changes, including VCAM-1 expression, in murine cardiac grafts. Transplantation. 1993 Feb;55(2):315-20.

Herskowitz A, Mayne AE, Willoughby SB, Kanter K, Ansari AA. Patterns of myocardial cell adhesion molecule expression in human endomyocardial biopsies after cardiac transplantation. Induced ICAM-1 and VCAM-1 related to implantation and rejection. Am J Pathol. 1994 Nov;145(5):1082-94.

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Principal Investigator

Referral Contact

For more information:

Michael A. Solomon, M.D.
National Institutes of Health Clinical Center (CC)
(301) 496-9320

Grace M. Graninger, R.N.
National Institutes of Health Clinical Center (CC)
National Institutes of Health
Building 10
Room 2C145
10 Center Drive
Bethesda, Maryland 20892
(301) 496-9320

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

Clinical Trials Number:


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