Acute Cellular Graft Rejection, Antibody-Mediated Graft Rejection, Cardiac Allograft Vasculopathy, Cardiac Death, Cardiac Transplant Disorder, Heart Failure, Heart Transplant Rejection, Immune Tolerance
Conditions
Keywords
Heart transplantation
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.
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.
Interventions
None listed
Sponsors
Lee S Nguyen
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Heart transplantation
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | up to five years after inclusion | all-cause mortality |
| Acute cellular rejection (ACR) | up to five years after inclusion | ACR, biopsy-proven |
| Antibody mediated rejection (AMR) | up to five years after inclusion | AMR, biopsy-proven |
| Acute kidney injury (AKI) | up to five years after inclusion | AKI, defined by a KDIGO criteria |
| Severe sepsis or septic shock | up to five years after inclusion | As defined by Surviving Sepsis Campaign |
| Cardiac allograft vasculopathy (CAV) | up to five years after inclusion | CAV, defined ISHLT |
Outcome results
None listed