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Noninvasive Methods to Monitor Graft Survival in Heart Transplant Patients

StatusCompleted
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Study Status, References

    Re-verified, no change to tracked fields

    v10

  2. Notable

    Enrollment target: 175 to 263

    Collaborators: 1 to 2

    Show what changed: Collaborators
    Clinical Trials in Organ Transplantation

    Study Status, Sponsor/Collaborators, Conditions, Study Designv9

  3. Minor

    Publications: 3 to 4

    Show what changed: Publications
    Starling RC, Stehlik J, Baran DA, Armstrong B, Stone JR, Ikle D, Morrison Y, Bridges ND, Putheti P, Strom TB, Bhasin M, Guleria I, Chandraker A, Sayegh M, Daly KP, Briscoe DM, Heeger PS; CTOT-05 consortium. Multicenter Analysis of Immune Biomarkers and Heart Transplant Outcomes: Results of the Clini [...]

    Study Status, Referencesv8

  4. Notable

    Primary and study completion dates changed from estimate of Jun 2010 to Jul 2011

    Trial status: Active, Not Recruiting to Completed; Study sites: 14 to 12

    Study Status, Sponsor/Collaborators, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locationsv7

  5. Minor

    Trial status: Recruiting to Active, Not Recruiting

    Site details revised at 14 of 14 sites

    Study Status, Contacts/Locationsv6

Show 4 earlier versions

  1. Minor

    Study sites: 12 to 14

    Study Status, Contacts/Locationsv5

  2. Minor

    2 amendments

    2 re-verifications since 2008-02-11, no change to tracked fields

    v3-v4

  3. Notable

    Trial status: Not Yet Recruiting to Recruiting

    Study sites: 14 to 12; Primary completion date: Jun 2010; Eligibility criteria shortened, about 54 words

    Show what changed: Eligibility criteria
    Inclusion Criteria: BodyAge greater than 10 and a body mass of 30 kg (66 lbs) or more On waiting list for a heart [...] ple organ transplants Previously received organ transplants Require revascularization prior to study entry Ejection fraction of 40% or more OR ejection fraction of 20% lower than baseline and require inotropic agents OR have fractional shortening of 20% or less or a 25% decrease from baseline AND require inotropic agents OR require inotropic agents due to Ca [...] Other comorbidities that, in the opinion of the site investi [...]

    Study Status, Study Design, Arms and Interventions, Eligibility, Contacts/Locationsv2

  1. Minor

    Study First Submitted

  • 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.
Injury of transplant tissue by a transplant recipient's immune system continues to be the leading cause of graft rejection and recipient death. The purpose of this study is to identify a single test or a combination of noninvasive tests currently used for heart transplant monitoring that correlate to long-term graft survival.
Trial Details
NCT Number NCT00466804
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), Clinical Trials in Organ Transplantation
Conditions Heart Transplant
Enrollment 263 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov