Prognosis Factors of Cardiac Complications After Liver Transplantation (PROCOM)
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|ClinicalTrials.gov Identifier: NCT02087371|
Recruitment Status : Completed
First Posted : March 14, 2014
Last Update Posted : February 5, 2018
|Condition or disease|
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|
|Actual Enrollment :||565 participants|
|Official Title:||Prognosis Factors of Cardiac Complications After Liver Transplantation|
|Actual Study Start Date :||January 2014|
|Actual Primary Completion Date :||April 2017|
|Actual Study Completion Date :||January 29, 2018|
Patients with end-stage liver failure and registered on transplantation list.
- 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.
- Describe prospectively cardiovascular complications after liver transplantation [ Time Frame: 1 year after liver transplantation ]
- Assess the impact of these complications on morbidity and mortality in intensive care at J28 and 1 year. [ Time Frame: 1 year after liver transplantation ]
- Gather a biological plasma and urine samples collection for study of new biomarkers. [ Time Frame: 7 days after liver transplantation ]
Biospecimen Retention: Samples With DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02087371
|Clichy la garenne, France, 92110|
|Principal Investigator:||Catherine PAUGAM BURTZ, Professor||Assistance Publique - Hôpitaux de Paris|