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

L

Lee S Nguyen

Status

Completed

Conditions

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

Study type

Observational

Funder types

Other

Identifiers

NCT03393793
CIC1421-18-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

566 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Heart transplantation

Exclusion criteria

  • None

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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