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NCT00042614 · ClinicalTrials.gov registry record
Study of Heart Transplant Rejection
A clinical trial, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- 188
- Enrollment target
NCT00042614: Completed study, sponsored by National Institutes of Health Clinical Center (CC).
NCT00042614 is a clinical trial that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 188 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00042614 has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- 188 participants
- Enrollment target
Study 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
Primary Outcome
Medical intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 188 participants |
| Start Date | 2003-04-07 |
What the finished NCT00042614 record still lists
NCT00042614 is an observational study that tracks outcomes without assigning an intervention. The registered 188 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00042614 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00042614 about?
NCT00042614 is a clinical study titled "Study of Heart Transplant Rejection". 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 substa...
What is the current status of trial NCT00042614?
This trial is currently completed. The enrollment target is 188 participants. The study started on 2003-04-07.
Who is sponsoring clinical trial NCT00042614?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
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