HEart trAnsplantation Registry of piTie-Salpetriere University Hospital
- Conditions
- Acute Cellular Graft RejectionAntibody-Mediated Graft RejectionCardiac Allograft VasculopathyImmune ToleranceCardiac DeathHeart Transplant RejectionCardiac Transplant DisorderHeart Failure
- Registration Number
- NCT03393793
- Lead Sponsor
- Lee S Nguyen
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 566
- Heart transplantation
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All-cause mortality up to five years after inclusion all-cause mortality
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
Acute cellular rejection (ACR) up to five years after inclusion ACR, biopsy-proven
Cardiac allograft vasculopathy (CAV) up to five years after inclusion CAV, defined ISHLT
Severe sepsis or septic shock up to five years after inclusion As defined by Surviving Sepsis Campaign
- Secondary Outcome Measures
Name Time Method