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NCT05895669 Clinical Trial

Cardiovascular Outcomes in Orthotopic Liver Transplanted Patients (COLT Study)

Death Clinical Trial

— COLT  

Official title:
Evaluation of Cardiovascular Outcomes in Patients Undergoing Orthotopic Liver Transplantation: a Retrospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05895669
Other study ID # 0012771/i
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 2, 2023
Est. completion date May 2, 2024

Study information
Verified date June 2023
Source University of Campania "Luigi Vanvitelli"
Contact Alfredo Caturano, MD
Phone +393338616985
Email alfredo.caturano@unicampania.it
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date May 2, 2024
Est. primary completion date May 2, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All patients with ortothopic liver transplantation and at least 2 year follow-up at the referral center Exclusion Criteria: - Missing Informed Consent Form - Missing Contact Informations for Follow up

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Gragnano Hospital Gragnano SA
Italy University of Campania Luigi Vanvitelli Napoli

Sponsors (1)
Lead Sponsor Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cardiovascular death death due to cardiac causes (myocardial infraction and/or stroke) 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
Primary cardiovascular complication fatal and non fatal myocardial infraction and/or stroke 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
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