Status:
UNKNOWN
Multicenter Clinical Trial to Evaluate the Efficacy of a Preventive Strategy Against CMV Infection in Heart Transplant Patients, Based on the Specific T Cells Response
Lead Sponsor:
Hospital Universitari de Bellvitge
Collaborating Sponsors:
Instituto de Salud Carlos III
Spanish Society of Cardiology
Conditions:
Heart Transplant Infection
CMV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study evaluates the efficacy and safety of an individualized preventive strategy against CMV infection in CMV seropositive heart transplant patients based on the specific basal response of the ly...
Detailed Description
Background: The prevention of Cytomegalovirus (CMV) infection in cardiac transplant patients is currently based exclusively on the performance of the serotypes of the receptor and the donor. Despite p...
Eligibility Criteria
Inclusion
- Adult patients (18 years or more), both sexes, heart transplant patients.
- Patients with positive IgG against CMV (seropositive).
- Informed consent given by the subject or his legal representative.
- Availability of obtaining recipient and donor serologies.
- Availability of obtaining biological samples of peripheral blood post-transplant to be able to perform the ELISPOT IFN-γ assay.
- Women of childbearing age who use effective contraceptive measures during and until, so less, 30 days after treatment. Men who use contraceptive measures of barrier during and for at least 90 days after treatment, unless there is certainty that the female partner does not run the risk of becoming pregnant.
Exclusion
- Pregnancy and / or breastfeeding period.
- Patients with contraindication for the use of valganciclovir or ganciclovir.
- Patients receiving thymoglobulin as induction therapy.
Key Trial Info
Start Date :
June 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 25 2023
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT04278547
Start Date
June 12 2020
End Date
March 25 2023
Last Update
December 23 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Universitari de Bellvitge
Barcelona, Spain, 08907