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
NCT ID: NCT04278547
Last Updated: 2020-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
188 participants
INTERVENTIONAL
2020-06-12
2023-03-25
Brief Summary
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In two thirds of the patients a preventive strategy will be carried out based on the result of the ELISPOT IFN-γ assay and in one third of the patients the standard of care strategy will be carried out (universal prophylaxis).
Detailed Description
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Objetives: To compare the cumulative incidence of CMV infection during the first year post-heart transplant amongst CMV seropositive recipients in 12 national centers, where the prophylactic strategy regarding CMV infection will be guided by the ELISPOT IFN-γ assay or not (control). Main variable: number of patients who have CMV infection in the first year post-trasplant (HT).
Hyphotesis: A preventive strategy against CMV infection in CMV seropositive heart transplant patients, based on the specific basal response of the T lymphocytes against CMV, ELISPOT IFN-γ assay, is effective, safe and not inferior than the control group in terms of infection CMV rates. Design: The investigators propose a phase IV clinical trial (with authorized treatment), randomized (2:1), controlled, open label and multicentric, with two parallel groups (Experimental group: preventive strategy based on the ELISPOT IFN-γ result: If patients are stratified as high risk they will receive prophylaxis with valgancyclovir for 3 months and if they are stratified as low risk they will be treated with preemptive therapy guided by CMV polymerase chain reaction analysis; Control group: Standard of care, universal prophylaxis with valgancyclovir for 3 months).
Follow-up: 1 year. Duration of the trial: 3 years. Sample size: 188 patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Experimental group
Preventive strategy based on the ELISPOT IFN-γ result: If patients are stratified as high risk they will receive prophylaxis with valgancyclovir for 3 months and if they are stratified as low risk they will be treated with preemptive therapy guided by CMV polymerase chain reaction analysis;
ELISPOT IFN-γ assay
ELISPOT IFN-γ diagnostic test: Evaluation of specific cellular immune response against the IE-1 antigen and the CMV pp65, using the technique ELISPOT IFN-γ and individualize the preventive strategy according to the result. In patients with a ELISPOT of "low risk" will be made advance therapy (preemptive therapy) guided by PCR of CMV In patients with a "high risk" ELISPOT, universal prophylaxis with valganciclovir will be performed oral (900 mg / 24h) or intravenous ganciclovir (5-10 mg / Kd / day) in case the oral route is not available.
Control group
Standard of care, universal prophylaxis with valgancyclovir for 3 months).
No interventions assigned to this group
Interventions
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ELISPOT IFN-γ assay
ELISPOT IFN-γ diagnostic test: Evaluation of specific cellular immune response against the IE-1 antigen and the CMV pp65, using the technique ELISPOT IFN-γ and individualize the preventive strategy according to the result. In patients with a ELISPOT of "low risk" will be made advance therapy (preemptive therapy) guided by PCR of CMV In patients with a "high risk" ELISPOT, universal prophylaxis with valganciclovir will be performed oral (900 mg / 24h) or intravenous ganciclovir (5-10 mg / Kd / day) in case the oral route is not available.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Patients with contraindication for the use of valganciclovir or ganciclovir.
* Patients receiving thymoglobulin as induction therapy.
18 Years
ALL
No
Sponsors
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Instituto de Salud Carlos III
OTHER_GOV
Spanish Society of Cardiology
OTHER
Hospital Universitari de Bellvitge
OTHER
Responsible Party
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Elena García Romero
Elena García Romero
Principal Investigators
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José González Costello
Role: PRINCIPAL_INVESTIGATOR
Cardiologist
Locations
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Hospital Universitari de Bellvitge
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Jose González Costello
Role: primary
Other Identifiers
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PI19/01610
Identifier Type: -
Identifier Source: org_study_id