Overview

This trial is active, not recruiting.

Condition hepatopathy
Sponsor Assistance Publique - Hôpitaux de Paris
Start date January 2014
End date January 2017
Trial size 500 participants
Trial identifier NCT02087371, AOR12132

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients with end-stage liver failure and registered on transplantation list.

Primary Outcomes

Measure
Cardiovascular complications
time frame: 1 year after liver transplantation

Secondary Outcomes

Measure
Describe prospectively cardiovascular complications after liver transplantation
time frame: 1 year after liver transplantation
Assess the impact of these complications on morbidity and mortality in intensive care at J28 and 1 year.
time frame: 1 year after liver transplantation
Gather a biological plasma and urine samples collection for study of new biomarkers.
time frame: 7 days after liver transplantation

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Prognosis Factors of Cardiac Complications After Liver Transplantation
Principal investigator Catherine PAUGAM BURTZ, Professor
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.