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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
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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

Condition or disease
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
Actual Enrollment : 565 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Describe prospectively cardiovascular complications after liver transplantation [ Time Frame: 1 year after liver transplantation ]
  2. 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 ]
  3. 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
Plasma and urines samples will be collected on 3 separate days (inclusion in the study, the day before liver transplantion and 7 days after).


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with end-stage liver failure and registered on transplantation list can participate to the study.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02087371


Locations
France
Hôpital Beaujon
Clichy la garenne, France, 92110
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Catherine PAUGAM BURTZ, Professor Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02087371     History of Changes
Other Study ID Numbers: AOR12132
First Posted: March 14, 2014    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No