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HEart trAnsplantation Registry of piTie-Salpetriere University Hospital (HEARTS)

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ClinicalTrials.gov Identifier: NCT03393793
Recruitment Status : Completed
First Posted : January 9, 2018
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Lee S Nguyen, Groupe Hospitalier Pitie-Salpetriere

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
Cardiac Transplant Disorder Cardiac Death Heart Failure Acute Cellular Graft Rejection Antibody-Mediated Graft Rejection Cardiac Allograft Vasculopathy Heart Transplant Rejection Immune Tolerance

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.

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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 : January 1, 2009
Actual Primary Completion Date : December 31, 2015
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: up to five years after inclusion ]
    all-cause mortality

  2. Acute cellular rejection (ACR) [ Time Frame: up to five years after inclusion ]
    ACR, biopsy-proven

  3. Antibody mediated rejection (AMR) [ Time Frame: up to five years after inclusion ]
    AMR, biopsy-proven

  4. Acute kidney injury (AKI) [ Time Frame: up to five years after inclusion ]
    AKI, defined by a KDIGO criteria

  5. Severe sepsis or septic shock [ Time Frame: up to five years after inclusion ]
    As defined by Surviving Sepsis Campaign

  6. Cardiac allograft vasculopathy (CAV) [ Time Frame: up to five years after inclusion ]
    CAV, defined ISHLT



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who underwent heart transplantation were included in this cohort.
Criteria

Inclusion Criteria:

  • Heart transplantation

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03393793


Sponsors and Collaborators
Lee S Nguyen
Investigators
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Study Director: Shaida Varnous, MD AP-HP, Pitié Salpétrière, Paris, France
Publications of Results:
Other Publications:
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Responsible Party: Lee S Nguyen, Principal Investigator, Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier: NCT03393793    
Other Study ID Numbers: CIC1421-18-01
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lee S Nguyen, Groupe Hospitalier Pitie-Salpetriere:
Heart transplantation
Additional relevant MeSH terms:
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Death
Pathologic Processes