HEart trAnsplantation Registry of piTie-Salpetriere University Hospital — HEARTS  

Heart Failure Clinical Trial

Official title: Heart Transplantation Registry of Pitié-Salpétrière University Hospital

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT03393793
• Study type: Observational
• Source: Groupe Hospitalier Pitie-Salpetriere
• Status: Completed
• Start date: January 1, 2009
• Completion date: December 31, 2017