Liver Transplant; ComplicationsCOLTNCT05895669
Cardiovascular Outcomes in Orthotopic Liver Transplanted Patients (COLT Study)
An observational study of Liver Transplant; Complications and Cardiovascular Complication, run by University of Campania Luigi Vanvitelli at 2 sites in Italy.
Trial summary
All patients with orthotopic liver transplantation who are evaluated and followed at each participating centers will be recorded in this study. Within this register a characterization of patients and therapy will be done. Prognostic factors of defined clinical relevant endpoints will be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant; Complications, Cardiovascular Complication, Cardiovascular; Attack
- How many people
- 100 participants
- Where
- 2 sitesItaly
- Study dates
- 2 May 2023to 2 May 2024
- 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
- Adult, Older adult
Study population: patients with ortothopic liver transplantation
Who may be able to join
- All patients with ortothopic liver transplantation and at least 2 year follow-up at the referral center
Who cannot join
- Missing Informed Consent Form
- Missing Contact Informations for Follow up
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Gragnano Hospital
Gragnano, SA, 80054
Carmine Coppola, MD
Carmine Coppola, MD
- Recruiting
University of Campania Luigi Vanvitelli
Naples, 80138
Alfredo Caturano, MD, alfredo.caturano@unicampania.it
Teresa Salvatore, MD
About this study
Official title: Evaluation of Cardiovascular Outcomes in Patients Undergoing Orthotopic Liver Transplantation: a Retrospective Cohort Study
All patients with orthotopic liver transplantation who are evaluated and followed at each participating centers will be recorded in this study. Within this register a characterization of patients and therapy will be done. Prognostic factors of defined clinical relevant endpoints will be evaluated.
- Conditions
- Liver Transplant; Complications, Cardiovascular Complication, Cardiovascular; Attack, Cardiovascular Stroke, Death
- Medical subject headings
- Myocardial Infarction, Death
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular death
death due to cardiac causes (myocardial infraction and/or stroke)
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
cardiovascular complication
fatal and non fatal myocardial infraction and/or stroke
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start2 May 2023
- Primary completion2 May 2024 (estimated)
- Study completion2 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfredo Caturano, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895669
- Sponsor's protocol ID
- 0012771/i
- Acronym
- COLT
- Status last verified
- Jun 2023
- First submitted
- 26 May 2023
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cardiovascular Outcomes in Patients Undergoing Orthotopic Liver Transplantation: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05895669
- Acronym / sponsor ID
- COLT / 0012771/i
- Conditions
- Liver Transplant; Complications, Cardiovascular Complication, Cardiovascular; Attack, Cardiovascular Stroke, Death
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 2 May 2024 (estimated)
- Study completion
- 2 May 2024 (estimated)
- First posted
- 8 Jun 2023 (actual)
- 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.
All patients with orthotopic liver transplantation who are evaluated and followed at each participating centers will be recorded in this study. Within this register a characterization of patients and therapy will be done. Prognostic factors of defined clinical relevant endpoints will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with ortothopic liver transplantation
Key inclusion criteria (1 listed)
- All patients with ortothopic liver transplantation and at least 2 year follow-up at the referral center
Key exclusion criteria (2 listed)
- Missing Informed Consent Form
- Missing Contact Informations for Follow up
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 death
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
death due to cardiac causes (myocardial infraction and/or stroke)
cardiovascular complication
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
fatal and non fatal myocardial infraction and/or stroke
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant; Complications and Cardiovascular Complication, run by University of Campania Luigi Vanvitelli at 2 sites in Italy.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alfredo Caturano, MD (+393338616985, alfredo.caturano@unicampania.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular death (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months). The study lists 2 primary outcomes in all. 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 8 Jun 2023.