Prognosis Factors of Cardiac Complications After Liver Transplantation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02087371

Acronym

PROCOM

Enrollment

565

Registered

2014-03-14

Start date

2014-01-31

Completion date

2018-01-29

Last updated

2018-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatopathy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
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
Gather a biological plasma and urine samples collection for study of new biomarkers.	7 days after liver transplantation

Countries

France

Outcome results