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Clinical Trials/NCT02087371
NCT02087371
Completed
Not Applicable

Prognosis Factors of Cardiac Complications After Liver Transplantation

Assistance Publique - Hôpitaux de Paris1 site in 1 country565 target enrollmentJanuary 2014
ConditionsHepatopathy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hepatopathy
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
565
Locations
1
Primary Endpoint
Cardiovascular complications
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
January 29, 2018
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Cardiovascular complications

Time Frame: 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 Outcomes

  • Gather a biological plasma and urine samples collection for study of new biomarkers.(7 days after liver transplantation)
  • 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)

Study Sites (1)

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