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Completed

NCT Number: NCT02087371

Prognosis Factors of Cardiac Complications After Liver Transplantation

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Beaujon

Clichy, 92110, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: PROCOM

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Mar 14, 2014
Registry last updated
Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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