Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT00042614 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Study of Heart Transplant Rejection

StatusCompleted
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 292 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor

    Re-verified, no change to tracked fields

  2. Minor

    Eligibility criteria expanded, about 13 words

    Publications: details revised at 2 of 3 entries

    Show what changed: Eligibility criteria
    * INCLUSION CRITERIA - for Transplant Patients: 1. Adult heart transplant center generally accepts patients wit [...] heart transplant patients must be 18 years of age or above. 2. Indication for cardiac transplantation as outlined by the 24 [...] onference on Cardiac Transplantation. These are as follows: * Peak VO(2) less than 10 ml/kg per minute or less than 50% of [...] l predicted VO(2) with achievement of anaerobic metabolism. * Severe cardiac ischemia consistently limiting routine activi [...] not amenable to surgical or percutaneous revascularization. * Recurrent symptomatic ventricular arrhythmias refractory to [...] [...]

  3. Minor

    48 amendments

    48 re-verifications since 2024-05-31, no change to tracked fields

    v243-v290

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT00042614
Lead Sponsor National Institutes of Health Clinical Center (CC)
Conditions Heart Transplantation
Enrollment 188 participants
Start Date
Updated on ClinicalTrials.gov