NCT03393793

HEart trAnsplantation Registry of piTie-Salpetriere University Hospital

Heart Transplantation Registry of Pitié-Salpétrière University Hospital

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 566 (actual)
• Sponsor: Lee S Nguyen · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Timeline

• Start date: 2009-01-01
• Primary completion: 2015-12-31
• Completion: 2017-12-31
• First posted: 2018-01-09
• Last updated: 2019-09-26