Prognosis Factors of Cardiac Complications After Liver Transplantation

NCT ID: NCT02087371

Last Updated: 2018-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

565 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2018-01-29

Brief Summary

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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

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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.

Conditions

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Hepatopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Included patients

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

\- Patients older than 18 years, on list for LT because of chronic hepatic disease.


\- emergency LT, patient under guardianship or trusteeship.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Catherine PAUGAM BURTZ, Professor

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hôpital Beaujon

Clichy, , France

Site Status

Countries

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France

Other Identifiers

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AOR12132

Identifier Type: -

Identifier Source: org_study_id

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