Prognosis Factors of Cardiac Complications After Liver Transplantation

Completed

• Conditions: Hepatopathy

• Registration Number: NCT02087371
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-22
• Study First Submitted QC: 2014-03-12
• Study First Posted: 2014-03-14
• Primary Completion: 2017-04
• Status Verified: 2018-01
• Study Completion: 2018-01-29
• Last Update Submitted: 2018-02-02
• Last Update Posted: 2018-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 565

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiovascular complications	1 year after liver transplantation	Identify risk factors for occurrence of cardiovascular complications in the year following the transplantation.; Cardiovascular complications include myocardial infarction, increase of cardiac troponin, cardiogenic pulmonary edema, cardiogenic shock, ventricular or supraventricular arrhythmia requiring treatment, de novo arterial hypertension and death of cardiac cause.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hôpital Beaujon; 🇫🇷 Clichy la garenne, France