Clinical trial NCT02087371: Prognosis Factors of Cardiac Complications After Liver Transplantation
Official title: Prognosis Factors of Cardiac Complications After Liver Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatopathy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-03-14
Enrollment: 565
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with end-stage liver failure and registered on transplantation list can participate to the study.

Brief summary: 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

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Cardiovascular complications
timeFrame: 1 year after liver transplantation
Secondary outcomes:
measure: Describe prospectively cardiovascular complications after liver transplantation
timeFrame: 1 year after liver transplantation
measure: Assess the impact of these complications on morbidity and mortality in intensive care at J28 and 1 year.
timeFrame: 1 year after liver transplantation
measure: Gather a biological plasma and urine samples collection for study of new biomarkers.
timeFrame: 7 days after liver transplantation
Other outcomes:
Locations:
city: Clichy la garenne
country: France
facility: Hôpital Beaujon
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Catherine PAUGAM BURTZ, Professor
role: PRINCIPAL_INVESTIGATOR
References: