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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 is a clinical trial that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 188 participants.

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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

Trial Details

FieldValue
Enrollment Target 188 participants
Start Date 2003-04-07

What the Registry Record Tells You About NCT00042614

The ClinicalTrials.gov registry entry for NCT00042614 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 188 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT00042614 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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