Prognosis Factors of Cardiac Complications After Liver Transplantation (PROCOM)

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

Study Overview

• Status: Completed
• Conditions: Hepatopathy

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 Type: Observational
• Enrollment (Actual): 565

Contacts and Locations

Study Locations

• France
  • Clichy la garenne, France, 92110
    • Hôpital Beaujon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with end-stage liver failure and registered on transplantation list can participate to the study.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Included patients; Patients with end-stage liver failure and registered on transplantation list.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Catherine PAUGAM BURTZ, Professor, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): January 29, 2018

Study Registration Dates

• First Submitted: January 22, 2014
• First Submitted That Met QC Criteria: March 12, 2014
• First Posted (Estimate): March 14, 2014

Study Record Updates

• Last Update Posted (Actual): February 5, 2018
• Last Update Submitted That Met QC Criteria: February 2, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: AOR12132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No