Prognosis Factors of Cardiac Complications After Liver Transplantation

NCT02087371 | Completed

• 1 other identifier: AOR12132
• Study Type: observational
• Target: 565
• Locations: 1 country
• Sites: 1

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

Conditions

Hepatopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

Included patients

Patients with end-stage liver failure and registered on transplantation list.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \- Patients older than 18 years, on list for LT because of chronic hepatic disease.
• \- emergency LT, patient under guardianship or trusteeship.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Beaujon

Clichy, 92110, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and urines samples will be collected on 3 separate days (inclusion in the study, the day before liver transplantion and 7 days after).

MeSH Terms

Conditions

Digestive System Diseases

Study Officials

• Catherine PAUGAM BURTZ, Professor

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2014
• First Posted: March 14, 2014
• Study Start: January 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: January 29, 2018
• Last Updated: February 5, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)