Prognosis Factors of Cardiac Complications After Liver Transplantation

Hepatopathy Clinical Trial

— PROCOM  

Official title:

Prognosis Factors of Cardiac Complications After Liver Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02087371
• Other study ID #: AOR12132
• Status: Completed
• Phase: N/A
• First received: January 22, 2014
• Last updated: February 2, 2018
• Start date: January 2014
• Est. completion date: January 29, 2018

Study information

• Verified date: January 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 565
• Est. completion date: January 29, 2018
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatopathy

Locations

Country	Name	City	State
France	Hôpital Beaujon	Clichy la garenne

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular complications	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.	1 year after liver transplantation
Secondary	Describe prospectively cardiovascular complications after liver transplantation		1 year after liver transplantation
Secondary	Assess the impact of these complications on morbidity and mortality in intensive care at J28 and 1 year.		1 year after liver transplantation
Secondary	Gather a biological plasma and urine samples collection for study of new biomarkers.		7 days after liver transplantation