Prognosis Factors of Cardiac Complications After Liver Transplantation (PROCOM)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Hepatopathy

Study type: Observational

Funder types: Other

Identifiers

NCT02087371

AOR12132

Details and patient eligibility

About

This is a prospective, multicenter, non-interventional, observational study of a cohort with a biological plasma and urine samples collection for the study of prognosis factors of cardiac complications after liver transplantation

Full description

Liver transplantation (LT) is the standard treatment for chronic or acute hepatic insufficiency with 87% of one-year survival. Cardiovascular complications are common after LT with an incidence at 6 months ranging between 25 and 50 %. These complications are associated with significant morbidity and represents the third cause of post LT mortality. Myocardial perfusion imaging or stress echocardiography, used for preoperative cardiovascular evaluation, are not enough efficient to predict the risk of post LT cardiovascular complications. However, to improve the prediction capacity of cardiovascular disease is fundamental in order to better select the candidates for LT or to develop preventive strategies. Such a strategy could reduce the morbidity and mortality from cardiovascular diseases after LT and improve the results of LT. Cardiovascular biomarkers such as troponin or natriuretic peptide are known to be predictive factors of postoperative cardiovascular complications in non cardiac surgery. The use of biomarkers in combination with conventional tests could improve the preoperative prediction of post LT cardiovascular complications.

Hypothesis: The preoperative biomarkers dosage could improve the prediction of cardiovascular complications occurring in the year after LT.

Enrollment: 565 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

• Patients older than 18 years, on list for LT because of chronic hepatic disease.

Non-inclusion criteria:

• emergency LT, patient under guardianship or trusteeship.

Secondary exclusion criteria:

• Patient out of list before liver transplant because of his death, his improvement, the existence of a contraindication
• Patient not presenting laboratory tests older than 1 year at the liver transplantaion.
• Patient included for over 2 years at the time of Liver transplantation.

Trial design

565 participants in 1 patient group

Included patients

Description:

Patients with end-stage liver failure and registered on transplantation list.