HepatopathyPROCOMNCT02087371
Prognosis Factors of Cardiac Complications After Liver Transplantation
An observational study of Hepatopathy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatopathy
- How many people
- 565 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to 29 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with end-stage liver failure and registered on transplantation list can participate to the study.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Hepatopathy
- Medical subject headings
- Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Included patients | Patients with end-stage liver failure and registered on transplantation list. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular complications
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.
Measured: 1 year after liver transplantation
Secondary outcomes (3)
Describe prospectively cardiovascular complications after liver transplantation
Measured: 1 year after liver transplantation
Assess the impact of these complications on morbidity and mortality in intensive care at J28 and 1 year.
Measured: 1 year after liver transplantation
Gather a biological plasma and urine samples collection for study of new biomarkers.
Measured: 7 days after liver transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionApr 2017
- Study completion29 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatopathyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 565 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine PAUGAM BURTZ, Professor, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087371
- Sponsor's protocol ID
- AOR12132
- Acronym
- PROCOM
- Status last verified
- Jan 2018
- First submitted
- 22 Jan 2014
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis Factors of Cardiac Complications After Liver Transplantation
- ClinicalTrials.gov ID
- NCT02087371
- Acronym / sponsor ID
- PROCOM / AOR12132
- Conditions
- Hepatopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 565 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- 29 Jan 2018 (actual)
- First posted
- 14 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Included patients | – | –Patients with end-stage liver failure and registered on transplantation list. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with end-stage liver failure and registered on transplantation list can participate to the study.
Key inclusion criteria (7 listed)
- Patients older than 18 years, on list for LT because of chronic hepatic disease.
- emergency LT, patient under guardianship or trusteeship.
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine PAUGAM BURTZ, Professor principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatopathy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular complications (time frame: 1 year after liver transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018; AzTrials last refreshed its copy on 8 Nov 2026.