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HEARTS: HEart trAnsplantation Registry of piTie-Salpetriere University Hospital

Sponsor
Lee S Nguyen (Other)
Overall Status
Completed
CT.gov ID
NCT03393793
Collaborator
(none)
566
Enrollment
108
Actual Duration (Months)

Study Details

Study Description

Brief Summary

Heart transplantation (HTx) is a procedure which is hindered by several complications. The HEARTS registry aims to allow the analysis of risk factors of all post-HTx complications. It consists in an exhaustive data collection at the moment of inclusion, i.e. HTx, knowing that patients underwent a full-fledged evaluation beforehand to evaluate their aptitude to being transplanted.

Post-HTx complications include but is not limited to: all-cause mortality, AMR, ACR, CAV, AKI, sepsis, cancer, psychological disorders, metabolic disorders.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Heart transplantation (HTx) is a procedure which is hindered by several complications. The HEARTS registry aims to allow the analysis of risk factors of all post-HTx complications. It consists in an exhaustive data collection at the moment of inclusion, i.e. HTx, knowing that patients underwent a full-fledged evaluation beforehand to evaluate their aptitude to being transplanted.

    Post-HTx complications include but is not limited to: all-cause mortality, AMR, ACR, CAV, AKI, sepsis, cancer, psychological disorders, metabolic disorders.

    To do so, patients are routinely monitored several times per year, the frequency of which depends on the proximity to the HTx.

    An endomyocardial biopsy is performed 3 times per month starting on day 15 until day 65 after HTx, then once every 20 days until four months, then monthly until six months, then once every 45 days until year 1, and every 3 months thereafter until year 2. Afterwards, they become twice per year until year 5, then once a year.

    An echocardiography is performed for every visit, with a complete blood analysis, including HLA antibodies screening with DSA evaluation, virologic evaluation.

    A coronarography is performed for the anniversary year of HTx, then once every 2 years.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    566 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Heart Transplantation Registry of Pitié-Salpétrière University Hospital
    Actual Study Start Date :
    Jan 1, 2009
    Actual Primary Completion Date :
    Dec 31, 2015
    Actual Study Completion Date :
    Dec 31, 2017

    Outcome Measures

    Primary Outcome Measures

    1. All-cause mortality [up to five years after inclusion]

      all-cause mortality

    2. Acute cellular rejection (ACR) [up to five years after inclusion]

      ACR, biopsy-proven

    3. Antibody mediated rejection (AMR) [up to five years after inclusion]

      AMR, biopsy-proven

    4. Acute kidney injury (AKI) [up to five years after inclusion]

      AKI, defined by a KDIGO criteria

    5. Severe sepsis or septic shock [up to five years after inclusion]

      As defined by Surviving Sepsis Campaign

    6. Cardiac allograft vasculopathy (CAV) [up to five years after inclusion]

      CAV, defined ISHLT

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Heart transplantation
    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Lee S Nguyen

    Investigators

    • Study Director: Shaida Varnous, MD, AP-HP, Pitié Salpétrière, Paris, France

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Lee S Nguyen, Principal Investigator, Groupe Hospitalier Pitie-Salpetriere
    ClinicalTrials.gov Identifier:
    NCT03393793
    Other Study ID Numbers:
    • CIC1421-18-01
    First Posted:
    Jan 9, 2018
    Last Update Posted:
    Sep 26, 2019
    Last Verified:
    Sep 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Lee S Nguyen, Principal Investigator, Groupe Hospitalier Pitie-Salpetriere
    Heart transplantation
    Additional relevant MeSH terms:
    Death

    Study Results

    No Results Posted as of Sep 26, 2019