Clinical trial NCT03393793: HEart trAnsplantation Registry of piTie-Salpetriere University Hospital
Official title: Heart Transplantation Registry of Pitié-Salpétrière University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Transplant Disorder
Cardiac Death
Heart Failure
Acute Cellular Graft Rejection
Antibody-Mediated Graft Rejection
Cardiac Allograft Vasculopathy
Heart Transplant Rejection
Immune Tolerance
Keywords: Heart transplantation
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
First posted: 2018-01-09
Enrollment: 566
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent heart transplantation were included in this cohort.

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.

Eligibility criteria: Inclusion Criteria:

* Heart transplantation

Exclusion Criteria:

* None

Primary outcomes:
measure: All-cause mortality
timeFrame: up to five years after inclusion
measure: Acute cellular rejection (ACR)
timeFrame: up to five years after inclusion
measure: Antibody mediated rejection (AMR)
timeFrame: up to five years after inclusion
measure: Acute kidney injury (AKI)
timeFrame: up to five years after inclusion
measure: Severe sepsis or septic shock
timeFrame: up to five years after inclusion
measure: Cardiac allograft vasculopathy (CAV)
timeFrame: up to five years after inclusion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AP-HP, Pitié Salpétrière, Paris, France
name: Shaida Varnous, MD
role: STUDY_DIRECTOR
References:
citation: Meng P, Nguyen LS, Jabbour F, Ogna A, Clair B, Orlikowski D, Annane D, Lofaso F, Fayssoil A. Accuracy of B-natriuretic peptide for the diagnosis of decompensated heart failure in muscular dystrophies patients with chronic respiratory failure. Neurol Int. 2018 Dec 20;10(4):7917. doi: 10.4081/ni.2018.7917. eCollection 2018 Dec 5.
citation: Nguyen LS, Coutance G, Salem JE, Ouldamar S, Lebreton G, Combes A, Amour J, Laali M, Leprince P, Varnous S. Effect of recipient gender and donor-specific antibodies on antibody-mediated rejection after heart transplantation. Am J Transplant. 2019 Apr;19(4):1160-1167. doi: 10.1111/ajt.15133. Epub 2018 Oct 29.